Shared Resources Job Openings

Overview

The Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization.  We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.   

The Quality Control laboratory performs in-process and release testing in support of Human Gene Therapy Phase I/II clinical research studies.

We are looking for a dynamic, skilled, and detail-oriented candidate to join our team. The position will perform routine cell-based potency assays, as well as microbial safety assays utilizing ELISA, microscopy, and qPCR techniques. In addition, the position will be required to follow and maintain laboratory quality systems in our GMP environment. Eventually, the position may also be required to train on flow cytometry-based methods.

Responsibilities

Analytic Developer/Quality Control Associate I:

• Perform routine microbiological, flow cytometry and cell culture based potency assays in support of manufacturing and process development activities. 
• Perform method development including assay qualification and generation of approved test methods.
• Further responsibilities include sample receipt/distribution, communication with internal/external laboratories, environmental monitoring activities and maintenance of the lab equipment in state of regulatory compliance.

Analytic Developer/Quality Control Associate II:

• Perform in-process, lot release, and stability cGMP testing of raw materials and human gene therapy products
• Review assays performed by peers
• Write SOPs and test methods
• Perform deviation and out of specification (OOS) investigations
• Maintain laboratory cell lines
• Participate in environmental monitoring activities
• Maintain equipment
• Perform general activities in accordance to SOPs and laboratory quality system

Qualifications

Analytic Developer/Quality Control Associate I

MINIMUM QUALIFICATIONS:

• At least a minimum of one year of experience in analytical methods used in QC release testing and characterization of immune cells and/or stem cells
• Hands on experience with analytical methods that such as:  FACS, cell culture based functional assays (e.g.  target cell killing, cytokine release), quantitative PCR, genetic and proteomic profiling, ELISA
• Experience in following and completing GMP test methods and documentation intended for product release testing and characterization as required under FDA and ICH guidelines
• Experience in executing protocols for the qualification/validation of methods and equipment
• Good communication skills and writing ability
• Familiarity with data analysis software packages and general statistical concepts and methods
• Bachelor's degree (or higher)

Analytic Developer/Quality Control Associate II

MINIMUM QUALIFICATIONS:

• Bachelor’s degree in a life sciences field with 2+ years, preferably with a background in biologics and/or cellular therapeutics
• Hands-on experience with microtiter cell-based assays
• Experience with aseptic and cell culture techniques
• Experience with typical GMP Quality Systems (ex. Document Control, Deviations, CAPA, Change Control, etc.)
• Good written and oral communication skills
• Strong communication and writing skills with demonstrated ability to work in a dynamic team environment

PREFERRED QUALIFICATIONS:

• Experience with cytotoxicity, bacterial endotoxin, and qPCR testing
• Experience with Environmental Monitoring (EM) programs   
• MA/MS Preferred

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.

The Animal Equipment Preparer processes the facilities’ soiled animal housing equipment and prepare for use.  Focus will be on gaining skills.  The incumbent works following established procedures in performing daily responsibilities. The Equipment Preparer  position reports directly to the Supervisor -Husbandry Systems Operations. This position is under close supervision with no responsibility for supervision others.  Incumbent is expected to acquire skills and knowledge to perform more advanced work through training. Uses limited discretion and judgement in carrying out tasks.  

The Equipment Preparer processes soiled animal housing equipment and prepares clean equipment for use; performs general custodial care for areas within the facility; and may assist with inventory assessment checks for equipment supplies.

Responsibilities

Housing Equipment Preparation: 

• Learn and become proficient in preparing items for the equipment washers, including removal of soiled bedding, sorting of items into similar batches, soaking designated items and scrubbing items that are especially soiled. 
• Be proficient at preparing orders of freshly prepared animal caging and rodent drinking water for the animal technicians. 

Equipment Operations: 

• Learn and become proficient at ensuring that clean equipment has been processed correctly and shows no sign of residual waste material or other types of contamination.
• Be proficient at notifying the Supervisor of any malfunctioning machinery or damaged equipment. 
• Be proficient in operation of equipment washers, autoclaves and automatic water filling systems including preparing the acidification solution for the water filing stations under supervision.  

Sanitation Operations:

• Learn and become proficient in performing housekeeping duties such as sweeping, mopping, garbage removal, and equipment washing in animal housing areas and surrounding premises. 
• Learn and become proficient in appropriate sanitation procedures and collection of materials for quality testing. 

Research Support: 

• Learn and become proficient at preparing and providing special equipment orders.  
• Know appropriate regulatory and safety regulations surrounding biomedical research. 

Perform other duties as assigned. 

Qualifications

MINIMUM QUALIFICATIONS:

• High school diploma or equivalent
• Have sufficient verbal and written communication skills to be able to follow written and verbal instructions and assimilate training
• Ability to lift and move 50 lbs on a regular basis and sustained physical activities such as bending, balancing, stooping, reaching, and remain standing for long periods of time
• Ability to wear Personal Protective Equipment including scrubs, gloves, shoe covers, gowns, ear plugs / muffs, face mask, and eye protection

PREFERRED QUALIFICATIONS:

• Maintenance of a valid Washington State Driver’s License and good driving record

Fred Hutchinson Cancer Center has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations. As a condition of employment, newly hired employees must, prior to their first day of employment:

Provide proof of being fully vaccinated against COVID-19 ; OR

Initiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider’s certification).

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization.  We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.   

The Animal Equipment Preparer processes the facilities’ soiled animal housing equipment and prepare for use.  Focus will be on gaining skills.  The incumbent works following established procedures in performing daily responsibilities. The Equipment Preparer position reports directly to the Supervisor -Husbandry Systems Operations. This position is under close supervision with no responsibility for supervision others.  Incumbent is expected to acquire skills and knowledge to perform more advanced work through training. Uses limited discretion and judgement in carrying out tasks.  

The Equipment Preparer processes soiled animal housing equipment and prepares clean equipment for use; performs general custodial care for areas within the facility; and may assist with inventory assessment checks for equipment supplies.

This position is eligible for a sign-on bonus, up to $1,000

Responsibilities

1. Housing Equipment Preparation: Learn and become proficient in preparing items for the equipment washers, including removal of soiled bedding, sorting of items into similar batches, soaking designated items and scrubbing items that are especially soiled.Beproficient at preparing orders of freshly prepared animal caging and rodent drinking water for the animal technicians. 
2. Equipment Operations: Learn and become proficient at ensuring that clean equipment has been processed correctly and shows no sign of residual waste material or other types of contamination. Be proficient at notifying the Supervisorof anymalfunctioning machinery or damaged equipment. Be proficient in operation of equipment washers, autoclaves and automatic water filling systems including preparing the acidification solution for the water filing stations under supervision. 
3. Sanitation Operations: Learn and become proficient in performing housekeeping duties such as sweeping, mopping, garbage removal, and equipment washing in animal housing areas and surrounding premises.Learn and become proficient in appropriate sanitation procedures and collection of materials for quality testing. 
4. Research Support:  Learn and become proficient at preparing and providing special equipment orders. 
5. Know appropriate regulatory and safety regulations surrounding biomedical research. 
6. Perform other duties as assigned.

Qualifications

MINIMUM QUALIFICATIONS:

• High school diploma or equivalent
• Have sufficient verbal and written communication skills to be able to follow written and verbal instructions and assimilate training
• Ability to lift and move 50 lbs on a regular basis and sustained physical activities such as bending, balancing, stooping, reaching, and remain standing for long periods of time
• Ability to wear Personal Protective Equipment including scrubs, gloves, shoe covers, gowns, ear plugs / muffs, face mask, and eye protection

PREFERRED QUALIFICATIONS:

• Maintenance of a valid Washington State Driver’s License and good driving record

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment. 

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures for the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.   

The Bioinformatician II provides specialized consulting and data analysis services to researchers at the Fred Hutch and across the wider Fred Hutch/UW Cancer Consortium. This position requires the ability to work independently, manage multiple overlapping data analysis projects, and communicate effectively with faculty, post-doctoral fellows, and research staff on a wide range of topics in biology, analysis of next-generation sequencing data, sound experimental design, and data science.

Responsibilities

The Bioinformatician II reports to the Associate Director of the Bioinformatics Shared Resource and will work with Fred Hutch scientists to refine computational research questions, develop analytical processes applied to large genomic datasets, and provide timely results and documentation for processes used.

Job Duties

• Perform quality control and end-to-end analysis of large sequence datasets from diverse workflows
• Consult with researchers to refine research questions and to develop sound experimental designs
• Identify best-practice bioinformatics tools and strategies to meet the needs of proposed projects
• Provide figures and written sections describing methods and results for manuscripts, presentations, and grant applications
• Partner with researchers who are developing novel assays to design appropriate processing and analysis workflows
• Collaborate with colleagues in the Genomics Shared Resource and the Hutch Data Core to ensure the integrity and consistency of primary data, track experimental methods and metadata, define standardized analysis pipelines, and provide training and support as users analyze and interpret results

Qualifications

• MS or PhD in bioinformatics, computational biology, genetics, or related field
• At least three years’ professional experience with computational analysis of complex sequence-based data sets including some of these assays: whole exome sequencing; targeted amplicon sequencing; somatic variant calling; bulk RNA-seq expression ; single-cell expression and immune repertoire profiling; CUT&RUN; ChIP-seq; ATAC-seq; or CRISPR/Cas9 knockout screens
• Demonstrated fluency in R or Python 3, ideally both
• Proficiency with Linux/Unix shell scripting (e.g., bash)
• Strong organizational skills, including the ability to manage and prioritize multiple competing tasks
• Excellent written and verbal communication skills

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.

The Biologics Associate II/III is responsible for all aspects of Biologics GMP and development material product production, from cell culture scale up through production in bioreactors (or other technologies) to product purification and bulk fill. Products include biological therapeutics such as monoclonal antibodies, plasmids and viral vectors for clinical and research use.

Responsibilities

• Plan for and execute GMP manufacturing operations per the production schedule.
• Scale up of cell culture and purification procedures from development to production levels
• Assist in the development of purification schema appropriate to each product
• Adapt alternative technologies to support production activities
• Train and mentor junior personnel, including cross training to provide backup capabilities
• Create or revise documentation for GMP operations, including batch records and standard operating procedures
• Initiate and investigate deviations and assist in development of CAPA.
• Support timely closure of deviation reports and CAPA
• Support the improvement and implementation of all GMP procedures and policies related to manufacturing operations
• Monitor and maintain equipment including autoclaves, bioreactors, incubators and chromatography equipment
• Assist with facility cleaning, culture vessel de-pyrogenation, assembly and sterilization
• Interface with and assist Quality Control in coordinating sample submission for product testing and facility monitoring
• Demonstrate technical acumen, operational understanding and GMP compliance in the maintenance of the Biologics Processing Facility.
• Maintain a high level of quality and safety standards.
• Analyze and evaluate the effectiveness of manufacturing methods, costs and results.
• Maintains appropriate level of training and meets compliance standards.
• Evening and/or work may occasionally be required based on project need.

Qualifications

Minimum Qualifications Biologics Associate II:

• Bachelor’s degree in Biology, Chemistry or related scientific major or equivalent.
• 1-2 years of experience in a biologics production facility or equivalent.
• Experience in aseptic processing techniques.
• Experience with clinical GMP product production with a thorough understanding of cGMP requirements for clinical manufacturing.
• Cell culture expansion experience.
• Experience with process equipment such as bioreactors and/or chromatography equipment.
• Excellent communication skills, both oral and written.
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Must be able to don and wear appropriate clean room attire and have the ability to wear all required Personal Protective Equipment (PPE).
• Must have the ability to lift a minimum of 25 pounds, the ability to stand for extended periods and use stepladders.
• Must have the ability to stand for long periods.

Minimum Qualifications Biologics Associate III:

• Bachelor’s degree in Biology, Chemistry or related scientific major or equivalent.
• 3-5 years of experience in a biologics production facility or equivalent.
• Robust experience in aseptic processing techniques.
• Experience with clinical GMP product production with a thorough understanding of cGMP requirements for clinical manufacturing.
• Cell culture expansion experience.
• Experience with process equipment such as bioreactors and/or chromatography equipment.
• Ability to work with limited supervision and troubleshoot and investigate operational issues.
• Excellent communication skills, both oral and written.
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Must be able to don and wear appropriate clean room attire and have the ability to wear all required Personal Protective Equipment (PPE).
• Must have the ability to lift a minimum of 25 pounds, the ability to stand for extended periods and use stepladders.
• Must have the ability to stand for long periods.

Preferred Qualifications:

• Experience with protein purification.
• Familiarity with multiple technologies for culture of mammalian and prokaryotic (bacterial cell culture; fermentation) cells at various scales of production.
• Experience with DNA plasmid prep and viral vector production.
• High level of comfort in dealing with specialized mechanical and electronic equipment.
• Familiarity with disposable technologies such as Single Use Bioreactors (SUB).

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

This position, reporting to the Manufacturing Manager, is responsible for leading the cGMP manufacturing team in the production of cellular and gene therapies in support of clinical research studies. This position oversees a team of professional associates responsible for the cGMP manufacture of cell and gene therapies within the Cell Processing Facility (CPF). The position addresses operational and routine challenges as they arise for Phase I/II manufacturing. Knowledge of cell culture and aseptic operations is essential. Demonstrated leadership and communication skills along with a strong working knowledge of the regulatory compliance requirements for the production of cell and gene therapies used in clinical studies are essential.

Responsibilities

• Provide guidance when deviations arise from approved policies and procedures. Investigate and write deviation reports and develop CAPA.
• Oversee and participate in cell processing operations such as cell selection/depletion, expansion, stimulation, transduction, cryopreservation, and patient infusion preparation, following cGMP manufacturing guidelines for clinical products.
• Ensures completion of daily and weekly manufacturing schedules by production associates to achieve all production deliverables.
• Assists in the maintenance of the production schedule to meet customer and business goals.
• Ensures that the facility and all production equipment, such as single-use bioreactors, incubators, centrifuges, cell sorting/selection equipment, and controlled-rate freezers, is working properly and is appropriately maintained per quality standards.
• Works closely with cross-functional teams and production staff to troubleshoot operational processing and equipment problems.
• Evaluate current practices and operations and drive implementation of changes to improve performance.
• Responsible for training, coaching, and mentoring lab technicians and associates on production functions and all compliance requirements per policies, procedures, and quality systems.
• Participates in interviewing and hiring staff.
• Develop goals for direct reports on an annual basis and routinely monitor progress against those objectives. Conduct annual performance reviews of direct reports.
• Work with manufacturing and technical staff to create, revise, and edit SOPs, batch records and raw material and product specifications as needed.
• Review and approve various GMP documentation in a timely fashion.
• Communicates status of operations, safety, maintenance or process issues in a timely manner to Area Management.

Qualifications

MINIMUM QUALIFICATIONS:

• Bachelor’s degree and 2-4 years of experience in a cell therapy/biologic production environment, or equivalent.
• Direct experience in aseptic processing techniques performed in a biosafety cabinet.
• Experience maintaining cell cultures.
• Solid understanding of cGMP requirements for clinical manufacturing.
• Ability to create and revise manufacturing documentation such as batch records, SOPs, deviation reports, and change controls.
• Ability to work with limited supervision in a fast-paced, dynamic, and highly regulated production environment.
• Excellent communication skills, both oral and written.
• Must have excellent communications skills, both verbal and written, within a diverse team environment.
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals, percentages, scientific notation, and basic algebraic and geometric calculations.
• Computer skills (MS Office).
• Must be able to wear clean room attire, surgical masks, and all required Personal Protective Equipment (PPE).
• Must have the ability to stand and to work in a biosafety cabinet for long periods.
• This position may require operation on a non-standard shift structure, for example, Sunday-Wednesday. Shifts are 4 days/week, 10 hours/day with some occasional weekend and holiday work.
• Meets physical requirements of the job, as follows: can lift a minimum of 25 pounds and the ability to bend, reach, stretch, and climb ladders.
• Ability to work non-standard shifts and occasional weekend days.

PREFERRED QUALIFICATIONS:

• Understanding of, and experience with, cell therapy/gene therapy clinical manufacturing.
• Experience actively managing direct reports.
• Experience with investigation methodologies, such as root cause analysis.

Fred Hutchinson Cancer Center has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations. As a condition of employment, newly hired employees must, prior to their first day of employment:
Provide proof of being fully vaccinated against COVID-19 ; OR
Initiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider’s certification).

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.

The primary responsibility of a Cellular Production Associate II-III is to execute manufacturing operations in the production of modified cellular products for patients participating in clinical protocols using cellular therapy. Clinical manufacturing in the Cell Processing Facility (CPF) requires following applicable current Good Manufacturing Practices (cGMP) in a cleanroom processing environment.

Responsibilities

• Utilizing aseptic techniques, perform a variety of open cell product manipulations in an ISO 5 biosafety cabinet.
• Follow Standard Operating Procedures (SOPs) and complete required processing documentation such as production batch records.
• Perform cell processing operations such as cell selection/depletion, expansion, stimulation, transduction, cryopreservation, and patient infusion preparation.
• Review executed GMP records for compliance with procedure.
• Identify deviations from approved policies and procedures. Document deviation, investigate occurrence, and contribute to CAPA development.
• Maintain and operate primary process equipment, such as incubators, centrifuges, cell sorting/selection equipment, and controlled-rate freezers.
• Participate in problem-solving and troubleshooting for cell processing operations and equipment. Assist in the evaluation of current practices and operations and help to implement changes to improve performance.
• Contribute to Corrective and Preventative Actions (CAPA) completion, and assist in the execution of change controls.
• Participate in quality/compliance improvement and technical development projects.
• Develop training skills, train junior associates.
• Act as Protocol Champion on existing protocols, assessing materials readiness using a Bill of Materials.
• As Protocol Champion, report production status and production run summary data.
• Assess the need for batch record updates and manage document change requests.

Qualifications

• Bachelor’s degree in a biological science or equivalent cGMP manufacturing bioprocessing experience.
• Minimum of five years experience (Cell Production Associate II) to eight years (Cell Production Associate III) of postgraduate experience related to process development and/or cGMP manufacturing. 
• Experience with open aseptic processing, working in biosafety cabinets.
• Experience with fundamentals of cell culture.
• Must be able to work efficiently, with strong attention to detail in a highly regulated environment.
• Proficiency with standard computer programs (MS Office).
• Must be able to support teamwork, and communicate effectively in a diverse team environment.
• Must demonstrate solid time management and organizational skills, and strong verbal and written communication.
• Must be able to wear clean room attire, surgical masks, and all required Personal Protective Equipment (PPE).
• Must have the ability to stand and to work in a biosafety cabinet for long periods.
• Meets physical requirements of the job, as follows: can lift a minimum of 25 pounds and the ability to bend, reach, stretch, and climb ladders.
• Ability to work non-standard shifts and occasional weekend days.

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization.  We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.   

Reporting to the Sr. Director of Therapuetics Products Program (TPP), the TPP Process Development (PD) group supports cell processing and manufacturing activities for early-stage cell therapy clinical trials, and performs technology advancement and development around selection, transduction, and ex-vivo expansion parameters of stem cells, T-cells, and B-cells.  PD works closely with internal Fred Hutch investigators and external collaborators to establish production processes for early phase clinical trials. Long term objectives are to develop efficient, cost-effective, and scalable processes so that these lifesaving therapies can be brought to patients in need.

The Process Development Director will provide technical and managerial leadership to the TPP Process Development group as well as serve as a technical and scientific resource for the entire TPP organization.  The position will ensure that development activities are well aligned with manufacturing needs, experiments are appropriately designed, and that results are effectively communicated to key stakeholders.  The successful applicant will interact on a daily basis with clinical trial sponsors, Process Engineering, Manufacturing, Product Management, QA/QC, research scientists, and senior Fred Hutch faculty and administration. 

Responsibilities

Specific responsibilities will include:

• Provide technical expertise for the PD department in the design and analysis of experiments and in presenting resultant data to groups inside and outside of the department in a succinct, well-organized and coherent manner.
• Ensure the appropriate management and maintenance of the PD laboratory facility and its equipment.
• Provide senior leadership for the PD department including hiring and management of staff and providing mentorship and staff development
• As a member of the TPP Leadership team, contribute to strategic planning in the development of TPP goals and objectives, and work with the other directors in providing leadership to the department.
• Partner with investigators in the development of processes that will meet their clinical requirements and address constraints associated with larger-scale manufacturing.
• Coordinate with Product Management and project sponsors to define the scope of development projects, including cost estimates and timelines.
• Partner with GMP Process Engineering and manufacturing staff to ensure appropriate transfer of needed processes and analytical information for successful clinical material production
• Use strong communication and teamwork skills to build relationships with all stakeholders (e.g., faculty, research staff, GMP manufacturing, QA/QC etc.)
• Provide input to the department annual operating budgets
• Identify opportunities for process improvements and champion their successful implementation.
• Publication of novel process improvements, meeting abstracts and/or talks, as appropriate.

Qualifications

MINIMUM QUALIFICATIONS:

• Ph.D. in immunology, bioengineering, cellular biology, or related field
• One or more years of GMP or GMP-related (e.g., process transfer, MFG audit response) experience
• 7+ years of research experience in immunology, cell biology or related field that would support process development role
• Experience as a personnel manager who has led/developed high performing teams.
• Experience with design of experiment (DOE) fundamentals and resultant data analysis (e.g. JMP)
• Experience with primary cells (e.g., T cells, B cells, stem cells, etc) and their isolation from primary sources, such as tissue and apheresis.
• Familiarity with cell culture media development and optimization of cell culture processes and operating conditions
• Familiarity with cell processing equipment such as Miltenyi CliniMACs or Prodigy, LOVO, cell counters, etc.
• Knowledge of analytical methods to characterize processes including cell-based assays, flow cytometry, and proteomic/genomic methods.
• Familiar with the resolution of issues associated with process scale-up and transfer into a GMP manufacturing environment
• Ability to perform short- and long-term project planning in terms of the generation of scope of work documents and project plans, resource demands, timelines, and budget forecasting
• Ability to prioritize multiple tasks, work under various timeline pressures, and drive tasks to completion
• Strong collaboration, team-building, communication and organizational skills required.

PREFERRED QUALIFICATIONS:

• 10+ years' experience in process development and supporting GMP cell culture based manufacturing operations. The ideal candidate will have experience in cell therapy applications with T-cells and stem cells; however, recognizing that this is a nascent field the candidate may have transferable skills from other biologics fields
• Strong expertise in CAR-T cell therapy development and optimization
• Experience working with adherent and suspension cell cultures in various flask, GRex and bioreactor systems (fed-batch/perfusion; fixed/disposable)
• Experience with single use bioreactor systems and associated in-process analytical equipment.
• Analytics method development and transfer.
• Knowledge of retroviral or lentiviral vectors and transductions processes/systems.
• Experience with cell culture associated unit operations such as tangential flow filtration for cell harvest/concentration, centrifugation, and cryopreservation/thaw recovery.

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment. 

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

The Flow Cytometry Specialist I/II will work as a member of the team to support the cytometry needs of the scientific community.

Responsibilities

The Flow Cytometry Specialist I works under the general supervision of the Flow Cytometry Director following procedures in performing daily responsibilities. The Flow Cytometry Specialist II works independently in performing daily responsibilities according to established procedures.

• Perform all aspects of instrumentation support including instrument maintenance, start up, calibration, quality control, and troubleshooting. (20%)
• Independently assist clients with the setup of their experiments. (20%)
• Assist clients in GLP, GMP, and BL2/3 environments. (15%)
• Maintain accurate department records including instrument use logs, materials used, supply inventories, capital equipment lists, equipment maintenance lists, department purchases and accounting records. (15%)
• Provide researchers advice in panel design and experimental troubleshooting. (15%)
• Perform other duties as required. (15%)

Qualifications

Flow Cytometry Specialist I

• Bachelor's degree in a physical or biological science or equivalent experience.
• Six months' experience in flow cytometry or lab utilizing flow cytometry desired.
• Familiarity with or experience in optical systems, instrument analysis, computers, or molecular and cell biology strongly desired.

Flow Cytometry Specialist II

• Bachelor's degree in a physical or biological science or equivalent experience and 3 years related experience.
• Familiarity with or experience in optical systems, instrument analysis, computers, or molecular and cell biology strongly desired.
• Must have 1+ year(s) experience working with flow cytometry either as a researcher using instrumentation or in a core facility/service roll.
• Demonstrated skill in working with electronics and machinery.
• Working knowledge of FlowJo software.
• Strong interpersonal and communication skills.

Fred Hutchinson Cancer Center has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations. As a condition of employment, newly hired employees must, prior to their first day of employment:

Provide proof of being fully vaccinated against COVID-19 ; OR

Initiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider’s certification).

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

The Shared Resources Administrative (SR Admin) team provides Core facilities with business support in areas including operations, fiscal management, billing, fund development, IT and HR.  The Intern works under the direction of the Administrative Manager.  This administrative position is responsible for assisting with the support, organization, and coordination of activities for Shared Resources and Research Administration.

Responsibilities

This internship role will require strong organizational and time management skills, attention to detail, the ability to effectively prioritize shifting tasks and to build strong working relationships.  Critical qualities also include exceptional written and oral communication, teamwork, good judgement, and professional conduct.

Essential Duties: 

1. Assist the Administrative Manager and staff with the implementation and administration of department projects, programs, and initiatives. (50%)

• Assist with data entry as it relates to department projects, programs, and initiatives.
• Act as a liaison with Shared Resources staff, answering questions and resolving problems regarding the administration of department projects, programs, and initiatives.

2. Assist the Administrative Manager and staff with coordinating large-scale communication efforts. (50%)

• Be a member of the Research Administration Employee Engagement Committee (EEC) and assist with planning department events such as the annual Open House.
• Assist with the planning, production, printing, and distribution of department communications.

Qualifications

Qualifications: 

• High School diploma or GED required 
• Currently enrolled in an undergraduate program 
• Strong Organization skills, attention to detail and accuracy, flexible with the ability to effectively manage time and prioritize multiple concurrent responsibilities
• Able to work independently and collaborate with a team to effectively meet deadlines
• A technical aptitude for learning new systems and applications is a plus

Preferred Qualifications: 

• 1 year of relevant experience 

Fred Hutchinson Cancer Center has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations. As a condition of employment, newly hired employees must, prior to their first day of employment:
Provide proof of being fully vaccinated against COVID-19 ; OR
Initiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider’s certification).

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

The primary responsibility of a Lab Technician I/II is to perform supports tasks for the production of modified cellular products for patients participating in clinical protocols using cellular therapy. Clinical manufacturing in the Cell Processing Facility (CPF) requires following applicable current Good Manufacturing Practices (cGMP) in a cleanroom processing environment.

Responsibilities

• Follow internal Standard Operating Procedures (SOPs) and complete necessary tasks related to area organization/cleanliness (eq. and not limited to; cleaning trap flasks, water baths, cryogenic containers, rinsing/kitting aspirating lines and submit for sterilization)
• Follow SOPs and complete required processing documentation such as logbooks and SOP forms.
• Maintain adequate levels of PPE, cleanroom garments, and sanitization supplies in entry and exit airlocks and dressing room.
• Keep formulations supplies ready by inventorying stocks and send necessary communication to the scheduler and/or designee.
• Identify deviations from approved policies and procedures and assist with initiating deviation records.
• Identify and communicate issues with equipment.
• Assist with other duties as requested by CPF leadership and processing teams.
• While performing job duties, consider current practices and suggest changes to improve performance.

Qualifications

Minimum Qualifications for Lab Technician I:

• High school diploma. Some experience in a laboratory setting preferred.
• Must be able to work efficiently, with strong attention to detail in a highly regulated environment.
• Must demonstrate solid time management and organizational skills.
• Must demonstrate solid teamwork and coordination capabilities.
• Computer skills preferred (MS Office).
• Must be able to wear clean room attire, surgical masks, and all required Personal Protective Equipment (PPE).
• Meets physical requirements of the job, as follows: can lift a minimum of 25 pounds and the ability to bend, reach, stretch, and climb ladders.
• Ability to work occasional weekend days or

Minimum Qualifications for Lab Technician II: 

• All qualifications listed above for a Lab Technician I and some college level course work in a laboratory science setting.  

Fred Hutchinson Cancer Center has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations. As a condition of employment, newly hired employees must, prior to their first day of employment:
Provide proof of being fully vaccinated against COVID-19 ; OR
Initiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider’s certification).

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.

The successful candidate will report directly to the Director of Therapeutic Products Program (TPP) Manufacturing.   This individual will work semi-autonomously to assist with  administrative and project management of preparations required for the manufacture of cell therapies in the Cell Processing Facility (CPF).  This will include routine communications and representation for internal and external clients regarding the production schedules and metrics reporting of manufacturing capacity.  The needed  skills and expertise for this position require the ability to analyze scheduling capacity opportunities and constraints, and to lead projects which will optimize scheduling and production capacity to ensure the efficient utilization of resources to meet the needs of the patients.

The Manufacturing Production Manager works independently and as part of the CPF Management team. The incumbent will interface with manufacturing, principal investigators and external collaborators including, but not limited to, the Cell Therapy Laboratory (CTL) and Apheresis Unit.  Strong interpersonal and communication skills, along with a focused attention to detail, are required to ensure successful coordination.

Responsibilities

May perform some or all of the following responsibilities:

• Work closely with Product Management to understand new projects intake process and with MFG Production Scheduler to understand the development of production pipeline development for manufacturing scheduling.
• Attend various meetings representing  CPF projects.
• Work with other MFG managers and supervisors to ensure understanding of current production scheduling status and resource needs.
• Assist with addressing problem solving and prioritization around the requirements of production for clinical protocols.
• Maintain and communicate manufacturing scheduling priorities, requirements and changes with manufacturing management, principal investigators, clinical nurses, QA, QC, CTL and Apheresis on a routine basis.
• Develop and maintain strong working relationships with customer groups to ensure proactive assessment of operations capabilities and  to support clinical needs.
• Serve as a point of contact for  CPF manufacturing production slot planning and related issues.
• Develop, compile and report production metrics to area management on a monthly, quarterly and annual basis.
• Be able to analyze data and evaluate capacity limitations so that the Production Schedule can be optimized.
• Drive projects for the implementation of improved scheduling tools and workflows to successful completion.

Qualifications

• Bachelor's degree.
• 5 years of experience in planning of manufacturing or clinical protocol execution(preferably in a Cell Therapy, Pharmaceutical or BioPharmaceutical discipline).  Experience with operations scheduling is preferred.
• Must be proficient in Microsoft Office (Excel, Word, PowerPoint) . Knowledge and experience with SharePoint is preferred.
• Strong organizational and interpersonal skills required.
• Must have strong intitiative, attention to detail,  problem solving and follow through.
• Must have strong customer service skills and excellent communication skills to effectively work with all levels of staff, both internally and externally.
• Willingness and capability to learn various aspects of cell therapy manufacturing operations in a GMP clean room environment.
• Willingness to learn additional departmental computer and software technologies.
• Ability to work independently on multiple projects and communicate status of projects to key decision makers on a proactive basis.
• Familiarity with requirements of GMP clinical production environments preferred.

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization.  We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.   

The Fred Hutch Therapeutics Products Program (TPP) encompasses two, distinct, clinical manufacturing facilities in support of Phase I/II clinical trials. Trials consist of both internal, faculty-driven protocols as well as external partnerships with peer institutions and industry partners.

The Quality Assurance Associate II/III is responsible for creating, developing, monitoring, and managing quality systems that support receipt, processing, testing and release for products manufactured by Therapeutic Products Program (TPP).  A person in this position works on complex problems requiring data analysis and the ability to perform an in-depth evaluation of regulations and policies in selecting methods and techniques for obtaining results. Tasks are typically carried out with no instruction on routine work and may provide guidance to other junior personnel. The Quality Assurance Associate III has additional responsibilities in leading project efforts and management of quality systems.

Responsibilities

• Supports the cGMP cell therapy and biologics manufacturing operations as the responsible person for Quality systems
• Performs the batch record reviews, product release and associated deviation records.  Perform the review and investigation on the deviation records to meet the quality compliance requirements.
• Provide Quality Assurance oversight throughout the end-to-end production operations assuring current GMP compliance requirements
• Supports self-auditing program to assure continual compliance with FACT standards and clinical regulatory requirements
• Ensures that the change management related to manufacturing methods are evaluated and implemented to meet GMP requirements and internal standards
• Review and approve procedures, master batch records, and other QA controlled documentation, and associated document change requests.
• Partner with functional areas to resolve product quality impacting investigations and own CAPA related to area of responsibility.
• Manage the Deviation/CAPA process to ensure issues are identified and appropriate corrective and preventative measures have been designed and completed in a timely manner
• Provide QA support for validations including reviewing protocols and reports
• Participate and support internal and external audits
• Provide support in review of specification and test methods
• Embody lean principles and methods while fostering a continuous improvement mindset

Qualifications

Minimum Qualifications for QA Associate II:

• Bachelor of Science degree required in a scientific discipline including pharmaceutical, biologics, or related field
• 3-5 years of cellular or biological manufacturing experience including quality assurance responsibilities or an equal combination of education and working experience
• Working knowledge of cGMP regulation
• Detail oriented team player with effective organization and execution skills
• Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment
• Must have the ability to stand for long periods
• Must be able to wear appropriate clean room attire and have the ability to wear all required Personal Protective Equipment (PPE)

Minimum Qualifications for QA Associate III:

• Bachelor of Science degree required in a scientific discipline including pharmaceutical, biologics, or related field
• 5-8 years of cellular or biological manufacturing experience including quality assurance responsibilities or an equal combination of education and working experience
• Working knowledge of cGMP regulation
• Detail oriented team player with effective organization and execution skills
• Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment
• Must have the ability to stand for long periods
• Must be able to wear appropriate clean room attire and have the ability to wear all required Personal Protective Equipment (PPE)

Fred Hutchinson Cancer Center has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations. As a condition of employment, newly hired employees must, prior to their first day of employment:

Provide proof of being fully vaccinated against COVID-19 ; OR

Initiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider’s certification).

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.

The Experimental Histopathology Research Histotechnologist I/II is responsible for providing routine and customized slide-based assays to support Fred Hutchinson research efforts. This individual will design and implement innovative immunohistochemistry (IHC) and/or in situ hybridization (ISH) protocols in collaboration with the Director and investigator supporting the project in a customer service based, team-oriented work environment. This role is also responsible for supporting routine histology services with tissue preservation and processing, slide preparation, staining and imaging.

Responsibilities

The Experimental Histopathology (EH) department provides an essential service of high quality and highly technical histology services support for Fred Hutch and external investigators. EH personnel perform all aspects of histology including tissue preservation, processing and basic to highly complex staining, digital imaging and image analysis for support of high impact research and publication. The Research Histotechnologist I is responsible for supporting general histology functions with routine tissue processing, paraffin and frozen sectioning, special stains and routine immunohistochemistry (IHC).  The Research Histotechnologist II will support general histology functions, up to 4-color multiplex IHC and single chromagenic in situ hybridization (ISH) protocol development and implementation. Individuals are responsible for making decisions to develop new protocols and methods based on independent research, previously documented protocols and experiments, personal knowledge and experience with guidance from the Manager, Director or delegate

Essential Tasks, Research Histotechnologist I:

• Support general histology functions with accessioning, tissue freezing, cyrosectioning, fixation, trimming, processing, paraffin embedding, sectioning, routine and specialized histochemical staining.
• Perform chromagenic immunohistochemistry (DAB IHC) and chromagenic in situ hybridization (ISH) staining using established protocols.
• Communicate with investigators on new and existing projects for routine histology, DAB IHC/ISH and advanced histology procedures. Use specialized histology experience and knowledge to advise on project design and troubleshoot. Use clear and concise communication skills to give project status updates and provide results at project completion.
• Perform brightfield and fluorescent imaging of microscope slides using Aperio digital slide scanning and imaging equipment or equivalent.
• Support general laboratory maintenance tasks as needed including reagent preparation, equipment maintenance, etc.

Essential Tasks, Research Histotechnologist II

• Perform all tasks listed for Research Histotechnologist I.
• Optimize new antibodies or probes for DAB IHC, DAB ISH staining or low-plex (4-color or less) multi-plex IHC staining. Research published sources, manufacturer provided data, historical EH protocols for efficient and effective testing to minimize cost and time needed for assay development. Analyze results with guidance of more experienced staff, if necessary, during optimization to troubleshoot and modify methods for reliable and reproducible results. Document protocols for accurate and efficient continuity of services.

Qualifications

Research Histotechnologist I

MINIMUM QUALIFICATIONS:

• A bachelor’s degree in a biological science and a minimum of two years of experience as a histology technician
• Strong troubleshooting skills and the ability to multi-task with precise attention to detail is especially critical
• To be successful in this position, the applicant must be capable of taking initiative and working independently

PREFERRED QUALIFICATIONS:

• Certification by a nationally recognized agency, such as the American Society of Clinical Pathology, is desired

Research Histotechnologist II

MINIMUM QUALIFICATIONS:

• Bachelor's degree
• 3 years relevant Histology/Pathology Experience plus at least 1 year of IHC experience
• Intermediate knowledge of IHC and/or ISH procedures
• Strong troubleshooting and problem solving skills
• Excellent written and verbal communication skills
• Ability to work positively in a customer oriented environment
• Ability to work independently, establish priorities and work concurrently on multiple projects
• Familiarity in Microsoft Excel, Word and Outlook
• Proficiency in basic histology skills: tissue processing, embedding, microtomy, cryosectioning and routine histochemical staining

PREFERRED QUALIFICATIONS:

• Familiarity with Leica Bond automated staining platforms
• Familiarity with Aperio or similar digital imaging systems
• Experience with optimizing new antibodies in IHC and brightfield digital imaging

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

The Research Technician I will perform routine animal husbandry tasks, including monitoring health and breeding status, weaning pups, and maintaining breeding records. This is considered an entry level position for individuals with no prior experience in laboratory animal care procedures. Focus will be on gaining skills.

Responsibilities

Scope of Responsibilities:

Works under the direction of the Principal Investigator, Director or higher-level laboratory personnel to complete tasks essential for the operation of the group. Incumbent is expected to acquire skills and knowledge to perform more advanced work through training. Uses limited discretion and judgement in carrying out tasks.

Essential Tasks:

• Responsible for breeding, weaning and identification of animals as assigned. (50%)
• Inspect animals for general health and report abnormalities to more senior level technicians. (5%)
• Maintains appropriate and detailed data for the investigator’s laboratory, animal health records, and IACUC-related aspects of project oversight. (25%)
• Learn to competently restrain and perform technical manipulations and procedures for all small animal species within the vivarium as assigned by supervisor. (15%)
• Must be versed in laboratory rodent housing, radiation safety, biohazard containment, rodent pathogens, and risk reduction measures as they pertain to facility activities. (2.5%)
• Perform other duties as required. (2.5%)

Qualifications

Minimum Qualifications

• BA/BS in a scientific field required. Must have scientific knowledge in the area of study and basic laboratory skills.
• Independent research experience in addition to school lab experience is preferred.

Fred Hutchinson Cancer Center has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations. As a condition of employment, newly hired employees must, prior to their first day of employment:
Provide proof of being fully vaccinated against COVID-19 ; OR
Initiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider’s certification).

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.

The Fred Hutch Antibody Technology Resource is nationally recognized for its novel monoclonal antibody discovery platform. The facility supports Fred Hutch research labs across all five divisions, generating antibodies for basic science needs as well as clinical diagnostic and therapeutic applications. Other clients include regional academic research institutes and biotech companies. The lab has been completely updated over the past five years with cutting-edge instrumentation for antibody discovery including: Molecular Devices ClonePixII colony picker, IntelliCyt iQue Screener, AKTA Pure autFPLC, Protein Simple WES capillary electrophoresis, Carterra and a $1.2M robot which automates significant parts of the antibody discovery process.

Responsibilities

Our group is seeking a Research Technician who will work with the resource director and other team members to carry out parts of the antibody discovery process. The successful candidate must have a desire to learn new skills. This is an excellent opportunity as training will be provided by experts in antibody discovery. This is a fast-passed, team-centric work environment which requires independence, organization, and time management skills.

• Specific responsibilities include:
• Animal immunization and other animal work
• Hybridoma generation
• Screening antibodies using flow cytometry
• Use and programing of liquid handling robots
• Use of ClonePixII
• Protein production and purification
• Antibody sequencing
• Running Carterra LSA machine

Qualifications

• Bachelor’s degree in related scientific field.
• Research Technician II – at least two years of full-time, post-bachelor’s laboratory experience.
• Research Technician III - at least three to five years of full-time, post-bachelor’s laboratory experience.Requires a bachelor’s degree in a scientific discipline
• Experience independently operating an AKTA including protocol generation and column packing
• Needs to consistently produce work of a very good standard
• Need to record information in an appropriate manner
• Needs to be good at communicate with researchers about work being carried out ongoing work
• Needs to perform tasks efficient with significant levels of multi-tasking

Fred Hutchinson Cancer Center has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations. As a condition of employment, newly hired employees must, prior to their first day of employment:
Provide proof of being fully vaccinated against COVID-19 ; OR
Initiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider’s certification).

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

Human survival has always hinged on the ability to translate visual signals into patterns, trends, and correlations. In the age of big data, this aptitude has proven effective at turning data into life-saving discoveries. As a member of the Hutch Data Core, you will work alongside scientists, software engineers, and biostatisticians to develop cutting-edge web and cloud solutions.

Your team will be primarily focused on three deliverables: 1) Web-based data atlases that currently enable the interactive exploration of over 7TB of research and reference data. 2) Web-based data portal that enables researchers to execute and evaluate bioinformatics pipelines. 3) Development of cloud-based bioinformatics analysis pipelines. Moreover, you will contribute to the cloud platform that underpins all these services. You should enjoy learning and applying new technologies and have a passion for data management, storage, and analysis tools.

As a member of a small team working at the intersection of science, statistics, and software, your success and job satisfaction will depend upon 1) Your ability to collaborate with researchers and members of the genomics and bioinformatics cores. 2) Desire to learn and apply new skills in a rapidly evolving field. 3) Ability to both execute and fail fast. To learn more about our team visit viz.fredhutch.org.

This is a senior level position that works under minimal supervision and works on complex projects requiring advanced knowledge and skills. The position may act as a lead or mentor over less experienced individuals.

Candidates for this position must think strategically, take initiative, and dive deep into details. Initiative, a customer-centric and creative mindset, and strong analytical skills are essential. Creativity is encouraged. The candidate for this position also embraces ambiguity, ramps up quickly on complex issues without oversight, and is skilled at communicating complex issues simply and convincingly to a wide range of audiences.

Responsibilities

• Designs and develops software applications for new products or product enhancements where no optimal software solutions exist
• Develops code to meet requirements and specifications of application
• Performs testing, troubleshooting, and debugging of application throughout the development process
• Follow software development best practices to design and develop software features to meet end user specifications
• Lead development of small to mid-sized projects
• Participate in code and design reviews
• Estimate software development tasks and participate in creating development and implementation schedules for features and applications
• Test & debug new and modified software
• Create application architecture and design for small to mid-sized projects
• Provide tier 3 support of software, troubleshoot user problems
• Create and maintain technical documentation
• Collaborate with and provide documentation for end users
• May be responsible for providing on-call support
• Perform other responsibilities as required

Qualifications

MINIMUM QUALIFICATIONS:

• Bachelor's degree or 5 years of related experience
• Experience with AWS Services (such as S3, Batch, Lambda, Amplify)
• Experience developing data driven applications and architecture
• Experience with modern programming languages such as TypeScript, Python, etc.
• Experience with version control systems such as git / GitHub
• Visualization experience (libraries such as D3, Vega, Highcharts, WebGL, etc.)
• Interest in biomedical research
   

PREFERRED QUALIFICATIONS:

• Bachelor's degree or 8 years of related experience
• Consuming or creating REST or GraphQL APIs
• Knowledge in genomics and related analytical toolkits
• Design tools such as the Adobe Suite or Sketch
• Experience working in the life sciences domain.

Fred Hutchinson Cancer Center has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations. As a condition of employment, newly hired employees must, prior to their first day of employment:
Provide proof of being fully vaccinated against COVID-19 ; OR
Initiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider’s certification).

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

This position, reporting to the TPP Operations Director, is responsible for all aspects of inventory maintenance in support of clinical trials for the Therapeutic Products Program. This position oversees a team managing the cGMP workflow for raw materials used to produce cellular and gene therapies in support of clinical research studies. Demonstrated leadership and communication skills along with working knowledge of the regulatory compliance requirements are required.

Responsibilities

• Oversee and participate in maintaining the workflows of manufacturing Materials Control such as receipt and inspection, identification, quarantine, release, storage, and issuance of GMP materials used in production.
• Ensure daily completion of monitoring, ordering, and handling of all supplies needed for operations.
• Follow Standard Operating Procedures (SOPs) and complete required documentation such as on logbooks and forms.
• Perform timely and accurate transactions in the business inventory control systems.
• Maintain the storage areas in an organized and sanitary environment. Ensure material location status and quantity are accurate.
• Conduct cycle counts, resolve inventory discrepancy issues.
• Administrate final product shipping/distribution to our customers.
• Identify issues, work collaboratively with the team to problem solve and implement changes.
• Provide guidance when deviations arise from approved policies and procedures. Investigate and write deviation reports and develop CAPA.
• Evaluate current practices and operations and contribute to changes to improve performance.
• Lead by example and take responsibility in the support of safety and cGMP compliance
• Report materials status/readiness to cross-functional project teams
• Ensure that equipment used for raw material storage, such as fridges and freezers, are working properly and are appropriately maintained per quality standards.
• Work with manufacturing and technical staff to create, revise, and edit materials-related SOPs and product specifications as needed.
• Responsible for training, coaching, and mentoring GMP Materials Control Specialists on materials functions and all compliance requirements per policies, procedures, and quality systems.
• Participates in interviewing and hiring staff.
• Develop goals for direct reports on an annual basis and routinely monitor progress against those objectives. Conduct annual performance reviews of direct reports.

Qualifications

• Bachelor’s degree, and 2-3 years of experience in Materials Control within regulated environment, such as cell therapy or biologics product, aerospace, or equivalent.
• Ability to work with limited supervision in a fast-paced, dynamic, and highly regulated environment.
• Previous experience in a supervisory role preferred.
• Must have excellent communications skills, both verbal and written, within a diverse team environment.
• Strong computer skills (MS Office).
• Must be able to wear clean room attire, surgical masks, and all required Personal Protective Equipment (PPE).
• Meets physical requirements of the job, as follows: can lift a minimum of 25 pounds and the ability to bend, reach, stretch, and climb ladders.

Fred Hutchinson Cancer Center has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations. As a condition of employment, newly hired employees must, prior to their first day of employment:
Provide proof of being fully vaccinated against COVID-19 ; OR
Initiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider’s certification).

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.

TPP (Therapeutic Products Program) is a GMP manufacturing organization within the Fred Hutch Cancer Research Center that executes process operations in the production of biologics in the Biologics Production Facility and modified cellular products in the Cell Processing Facility. The Process Engineering function within the TPP is responsible for Process Transfer from Process Development to the manufacturing group.

Responsibilities

PROCESS ENGINEER I

• Serve as primary author of GMP Manufacturing Batch Records and Validation Protocols and Reports, ensuring Process accuracy and GMP Compliance
• Serve as Subject Matter Expert (SME) for Manufacturing during the execution of Engineering Production Runs
• Conduct process specific training for MFG Operators prior to Engineering Run execution
• Ensure Manufacturing Readiness for TPP Engineering Runs
• Support execution of engineering runs in preparation for clinical operations
• Planning and execution of validation protocols
• Provide MFG data and process summaries to stakeholders following completion of production runs
• Process and implement feedback on GMP manufacturing batch records and GMP documentation
• Write and Revise MFG SOPs
• Implement continuous improvement Process Engineering projects
• Work within Quality Assurance (QA) document management systems
• On-board and qualify (IQ/OQ/PQ) GMP manufacturing equipment
• Provide support to quality system deliverables such as Deviation, CAPA, Change Management
• Provide support for investigations into Validation and MFG deviations
• Communicate and work cross-functionally to ensure proper process transfer.
• Serve as liaison between MFG and QA, QC and Process Development.
• Interface and collaborate with Principal Investigators and Process Development to ensure proper manufacturability and scalability of process
   

PROCESS ENGINEER II

Process Engineer II will be able to perform all duties of Process Engineer I in addition to the following:

• Design and execute engineering and validation study protocols
• Develop and implement process improvement opportunities
• Assist in troubleshooting and problem solving to simplify and improve efficiencies within MFG
• Assist in the development and utilization of tools to collect and process feedback on use of GMP documentation.
• Specify complex manufacturing equipment and systems requirements
• Lead teams in execution of Failure Mode Effects Analysis (FMEA)
• Design, implement, and verify effectiveness of Corrective Actions
• Implement cross-functional continuous improvement initiatives
• Provide training and guidance for Process Engineer I

Qualifications

PROCESS ENGINEER I

MINIMUM QUALIFICATIONS:

• BS in a Biological Science or Engineering, or relevant experience in biologics manufacturing specializing in microbial and mammalian cell culture and production of monoclonal antibodies, fusion proteins, conjugates, plasmids, viral vectors and peptide vaccines
• 3 years prior experience working within a Biotech production facility
• Knowledge in relevant math, science, validation, and engineering disciplines
• Working knowledge of equipment and technology as applies to job function
• Experience working in a regulated (GxP) environment, including a thorough understanding of GMP record keeping and documentation practices
• Strong technical writing skills, experience creating and revising SOPs, batch records, and validation protocols
• Solid troubleshooting and problem-solving skills
• Must be able to work efficiently, with strong attention to detail in a regulated environment
• Must be able to communicate effectively in a diverse team environment in support of team goals.
• Must demonstrate solid time management and organizational skills, with good verbal and written communication
• Experience with basic Microsoft Office Software (Word, Excel, Visio, etc.)
• Must be able to wear appropriate clean room attire and have the ability to wear surgical masks and all required Personal Protective Equipment (PPE)
• Occasional weekend and evening work required

PREFERRED QUALIFICATIONS:

• Experience working as a customer service provider in support of MFG
• Experience working in a biotechnology manufacturing environment
• Familiarity with Process Transfer workflows, tools and deliverables
• Familiarity with use of typical biotechnology equipment; fermenters, bioreactors, chromatography systems, etc
• Experience creating equipment SOPs for GMP clinical process equipment, and other GMP documents (reports, user requirements, etc.)
• Experience in assembling and reporting out production run summary data

PROCESS ENGINEER II

MINIMUM QUALIFICATIONS:

Process Engineer II will have all the minimum and preferred qualification of Process Engineer I in addition to the following:

• Advanced knowledge of GMP requirements as it applies to job function
• Demonstrated ability to effectively manage multiple tasks/projects utilizing organization and prioritization skills
• Strong trouble shooting and problem solving skills
• Experience executing Failure Mode Effects Analysis (FMEA)
• Experience in utilizing Root Cause Analysis for investigational purposes
• Demonstrated capability in completing Continuous Process Improvement projects

PREFERRED QUALIFICATIONS:

• Familiarity with various biotechnology process equipment such as bioreactor systems utilizing Applikon equipment and chromatography systems utilizing Unicorn
• Familiarity with equipment procurement and on-boarding

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion. 

JOB SUMMARY

The pathologist will participate in our missions of pathology diagnostic service, research collaboration, and education. The Veterinary Pathologist works with other pathologists, faculty, post-doctoral students, and staff members to provide diagnostic and research support in scientific programs that involve experimental manipulations of laboratory animals for various clinical and fundamental studies in cancer and infectious disease biology and therapeutics. Additionally, the veterinary pathologist may interpret human based studies. The Veterinary Pathologists also work with the Comparative Medicine Director to maintain and improve services offered within the resource. The Veterinary Pathologist reports directly to the Director of Translational Pathology.

Responsibilities

The Veterinary Pathologist provides support and training for all relevant pathology cases as well as to help develop new pathology-inclusive initiatives for Comparative Medicine and Experimental Histopathology.

PRIMARY JOB DUTIES

• Characterize and write summary reports regarding experimentally induced and natural occurring diseases in laboratory mice, rats, dogs, and occasional other research animal species used in the Center’s scientific programs.
• Collaborate with the Center’s research investigators in planning and performing studies of non-human subjects.
• Utilize clinical, gross, microscopic, cytological, clinicopathological, imaging data, and basic molecular techniques, including in situ hybridization during review of pathology cases in order to make comprehensive assessments.
• Collaborate with the Center’s scientists to comprehensively assess the pathobiology of genetically engineered mouse models, including different methods of phenotypic expression.
• Assist in preclinical development and safety evaluation of new therapeutic compounds
• Advise regarding the microbiological monitoring program for the Center’s laboratory rodent colonies, including relevant laboratory test platforms run in-house.
• Provide training in the appropriate methods of systemic gross necropsy evaluation and tissue collection for pathology cases.
• Assist in the writing of grant applications and other narratives for purchase of new equipment, development of new pathology-inclusive initiatives, and summary progress reports of funded projects.
• Serve as a member of the Center veterinary team regarding diagnosis, treatment and prevention of spontaneous diseases in animals.
• Assist the Director of Translational Pathology with project-specific tasks to maintain the quality of the resource and the cost-effectiveness of facility operations.
• Work with Shared Resources administrative personnel to establish fee schedules and policies for internal and external users.
• Review and annotate digital scanned slides for TMA production.
• Assist Experimental Histopathology technical staff in IHC and ISH validation and interpretation.
• Collaborate with center scientists on the design and interpretation of multiplex digital images (IHC and/or ISH).
• Keep current in the field by maintaining contacts with colleagues, attending conferences, attending training sessions, and advancing the knowledge base to meet the research needs of the Center’s scientific programs involving animals.
• Perform other responsibilities as required or as assigned by the Director.
• It is anticipated that 20% time will be devoted to professional improvement including research, conference attendance, manuscript preparation, Continuing Education requirement maintenance and committee service among others.

Qualifications

• Possess a DVM or equivalent degree from a veterinary college.
• Have 1-3 years’ experience working with laboratory rodents, including transgenic, knockout, and immunodeficient strains of mice in a veterinary pathologist role.
• Possess board certification by ACVP or ECVP or be board-eligible.
• Be conversant in the technology required to produce and maintain genetically modified populations of rodents and in the genetic monitoring necessary to assure their integrity.
• Be able to accurately describe and interpret gross and microscopic morphologic findings, present a pathologic diagnosis(s).
• Make recommendations for subsequent investigative studies at the cellular, ultrastructural, and/or molecular level to support the morphologic evaluations.

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.