Shared Resources Job Openings

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

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.

This position is responsible for Quality Control (QC) cGMP testing activities in support of Human Gene Therapy Phase I/II clinical research studies. 

This position will primarily focus on performing transfer, qualification, and validation of analytical test methods using FDA and ICH guidelines. In addition, the position will perform routine cell-based characterization and potency assays, as well as microbial assays utilizing flow cytometry, ELISA, microscopy, and qPCR techniques. Cross-training on multiple assays will be required for this position as well as in laboratory quality systems.

Responsibilities

• Lead and participate in analytical method transfer/qualification/validation activities
• Perform cGMP in-process, lot release and stability testing of raw materials and human gene therapy products
• Review assays performed by peers
• Perform deviation and out of specification (OOS) investigations
• Maintain laboratory cell lines
• Write SOPs and test methods
• Perform general laboratory activities in accordance to SOPs and laboraotry quality systems 

Qualifications

• Bachelor’s degree in a life sciences field
  • Analytic Dev/QC Associate III- Minimum of 5 years of related experience or 2+ years post Master's degree 
  • Analytic Dev/QC Associate IV- Minimum of 6 years of related experience or 3+ years post Master's degree 
• Knowledge of regulatory guidance documents/information for Analytical Procedures and Method Validation
• Knowledge of cGMP requirements for Phase I/II clinical trials
• Familiarity with Chemistry. Manufacturing, and Controls (CMC) information for Investigational New Drug Applications
• Experience with microtiter plate cell-based assays
• Familiarity with flow cytometry, ELISA, qPCR and HPLC techniques
• Knowledge of aseptic and cell culture techniques   
• Good written and oral communication. Good presentation skills
• Detail oriented, organized, proactive and self-motivated
• Possess strong communication and teamwork skills
• Ability to analyze data, assess/evaluate trends and make recommendations for improvement
• Experience with typical Quality Systems (ex. Document Control, Deviations, CAPA, Change Control, etc.)

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

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

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.

This position is responsible for all aspects of product production, from cell culture scale up through production in bioreactors (or other technologies) to product purification. Products include biological therapeutics such as monoclonal antibodies, plasmids and viral vectors for clinical research use. Evening and/or weekend work may occasionally be required based on project need.

Responsibilities

• Scale up of cell culture and purification procedures from research levels to production levels
• Developing purification schema appropriate to each product
• Adapt alternative technologies to support production activities
• Train and mentor personnel, including cross training to provide backup capabilities
• Assist Management with the development of documentation for resource operations, including batch records and standard operating procedures
• 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 product testing and facility monitoring
• Demonstrate technical acumen, operational understanding and GMP compliance in the maintenance and continued expansion of the Biologics Processing Facility
• Support the improvement and implementation of all GMP procedures and policies related to manufacturing operations
• 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
  
  

Qualifications

Required qualifications:

• Bachelor’s degree in Biology, Chemistry or related scientific major or equivalent
• Experience in aseptic processing techniques and a thorough understanding of biologics clinical manufacturing required
• Thorough understanding of cGMP requirements for clinical manufacturing
• Ability to work with limited supervision and to handle problems of a more difficult nature
• 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

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)

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

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

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 Cell Therapy Production Facility (CPF) is a department within the Therapeutic Products Program division that manufactures T-cell and stem cell therapeutic products for clinical trials. Within the CPF, there is a functional unit that supports clinical manufacturing by creating and/or revising manufacturing production batch records and SOPs. This position will oversee Process Engineering Specialists, Validation Engineers and MFG Protocol Champions in the development and creation of these GMP documents. They will also be responsible for development, facilitation and oversight of internal process and technology transfer from scientific and Process Development staff to Manufacturing personnel.

Responsibilities

The CPF Process Engineering Manager/Sr. Manager will primarily focus on Process Transfer and the oversight of MFG batch record development, creation and revision, with appropriate support of standard operating procedures, to ensure a continued state of regulatory compliance and continuity of clinical manufacturing operations. Job duties include:

• Track, schedule and ensure on-time completion of required GMP clinical MFG batch records and SOP documentation
• Manage Process Engineers and oversee Protocol Champions in the creation and revision of MFG operations documentation used in the execution of operations
• Interface and collaborate with Principal Investigators, Process Development, and Manufacturing staff in support of internal process transfer to ensure appropriate manufacturability and scalability of processes
• Lead and/or facilitate cross-functional teams in various projects and initiatives designed to improve process transfer and operations documentation deliverables
• Identify and articulate to stakeholders, Continuous Process Improvement opportunities, and assist in trouble shooting and problem solving to simplify and improve efficiencies within MFG
• Assist in the development, and utilize tools, to collect and process feedback on use of GMP documentation
• Assist in the coordination of process transfer activities with adherence to clinical production milestones and timelines
• Within GMP systems, support and organize technology transfer for new MFG equipment selection, procurement, onboarding and validation
• Lead process equipment commissioning and qualification activities
• Support execution of development and engineering runs in preparation for clinical production

Qualifications

Required for the Manager Level:

• BS/MS in a biological science with 5+ years (4+ years with MS) or relevant background in biologics and/or cellular therapeutics operations
• Experience working in a regulated (GMP) environment, including a thorough understanding of GMP record keeping and documentation practices
• Experience authoring batch records and SOPs
• Experience with basic Microsoft Office Software (Word, Excel, Visio, etc.)
• Strong verbal and written communication skills with demonstrated ability as a technical author of GMP documentation
• Experience with management and supervision of personnel
• Experience working as a customer service provider

Required for the Sr. Manager Level: 

• 7+ years relevant experience in biologics and/or cellular therapeutics operations is expected.
• Significant prior experience managing and leading a team.
• Demonstrated skill in contribution to and making strategic decisions for their department

Preferred:

• Experience designing and developing process transfer tools and workflows
• Strong administrative and logistics skills required to track a large variety and volume of tasks simultaneously
• Strong troubleshooting and problem solving skills
• Experience working in GMP cellular therapeutics and/or biologics manufacturing environment
• Ability to create presentations of data and run summaries of executed production runs
• Experience with preparation of validation documentation and execution against validation protocols

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

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

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 Cell Processing Facility Supervisor 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.  The successful candidate will oversee a team of professional associates responsible for the cGMP manufacture of cell and gene therapies within the Cell Processing Facility (CPF).  The successful candidate will address 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.

Available Shift: Sunday - Wednesday, 4/10 schedule, 7AM - 5:30PM

Responsibilities

• Oversee daily production process activities for cGMP manufacturing of clinical products in the CPF. 
• Assigns tasks to production associates to ensure completion of daily and weekly manufacturing schedules 
• Responsible for daily organization, ensuring work flows, delegating resources, and managing support to achieve production deliverables 
• Assists in the maintenance of the production schedule to meet customer and business goals 
• Ensures that the facility and all production equipment is working properly and are appropriately maintained per quality standards. 
• Works closely with cross functional teams and the production staff to troubleshoot process and equipment problems 
• Responsible for training, coaching and mentoring 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. 
• Working with manufacturing and technical staff, 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 
• Other duties as assigned. 

Qualifications

Required:

• Bachelor's degree and 2-4 years of experience in a cell therapy/biologics production environment or equivalent. 
• Direct experience in aseptic processing techniques performed in a biosafety cabinet. 
• Experience maintaining cell cultures. 
• Has a solid understanding of cGMP requirements for clinical manufacturing. 
• Ability to create and revise manufacturing documentation such as batch records, SOPs and deviation reports. 
• Ability to work with limited supervision in a fast paced and dynamic production environment. 
• 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. 
• Computer skills; MS Excel, Word, Outlook 
• Meets physical requirements of the job, as follows:  must have the ability to lift a minimum of 50 pounds, the ability to bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks. 
• Must have the ability to stand for long periods. 
• Must be able to wear appropriate clean room attire and have the ability to wear surgical masks and all Personal Protective Equipment (PPE). 
• This position may require operating 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. 

Preferred: 

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

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

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

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 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.

Please note the work schedule for this position is: Sun-Wed, 7AM-5:30PM

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 documentation trends and suggest and implement documentation improvements
• Identify deviations from approved policies and procedures. Document deviation, investigate major occurrences, and develop CAPA
• Maintain and operate primary process equipment, such as incubators, centrifuges, cell sorting/selection equipment and controlled rate freezers
• Take an active role in problem solving and troubleshooting of cell processing operations and equipment. Evaluate current practices and operations and contribute to changes to improve performance
• Lead Corrective and Preventative Actions (CAPA) completion, and author change controls
• Lead quality/compliance improvement and technical development projects
• Provide guidance and training to junior staff
• Work with Process Engineering and GMP Systems to assist with equipment on-boarding and validation projects
• Act as Protocol Champion on new protocols, as a point of contact for manufacturing readiness and execution, in internal and client-facing teams
• As Protocol Champion, assess materials readiness using a Bill of Materials
• As Protocol Champion, report production status and production run summary data as needed
• Assess the need for batch record updates and manage document change requests

Qualifications

• Bachelor’s degree in a biological science and a minimum of one year of postgraduate lab experience or 6 months+ professional GMP experience. A minimum of four years of related lab experience with a high school diploma is acceptable in lieu of Bachelor’s degree in biological science.   
• Experience establishing and maintaining long-term T-cell lines/clones preferred.  
• Computer skills highly desirable (Mac and PC).  
• 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 or evenings 

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

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

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 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 and a minimum of one year of postgraduate lab experience or 6 months+ professional GMP experience. A minimum of four years of related lab experience with a high school diploma is acceptable in lieu of Bachelor’s degree in biological science.   
• Minimum of 3 years of postgraduate lab experience is required to qualify for the CPA II level
• Experience establishing and maintaining long-term T-cell lines/clones preferred.  
• Computer skills highly desirable (Mac and PC).  
• 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 or evenings 

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

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

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.

This position principally involves clinical veterinary care for laboratory rodents, large animals and fish in cancer and related disease research programs. The Clinical Veterinarian will assist the Comparative Medicine (CM) veterinary staff in providing oversight of animal welfare compliance in accordance with applicable federal, state, local and institutional laws, policies, guidelines, and procedures (USDA, PHS, AAALAC, etc.) and may serve as member or as an alternate member of the Fred Hutch Institutional Animal Care and Use Committee.

Responsibilities

Scope of Responsibilities:

This position reports to the CM Sr. Director and works independently in providing clinical veterinary care to the Center’s research animals. The Clinical Veterinarian (CV) will support training of Comparative Medicine staff regarding veterinary procedures on laboratory animals. The CV provides veterinary medical and surgical care, including emergency services, as needed for all laboratory animals housed at the center. The CV interfaces with investigators regarding animal health, experimental design and IACUC related issues and ensures that compliance oversight (USDA, PHS, AAALAC, IACUC, etc.) is maintained. The CV also oversees staff regarding provision of adequate veterinary care and provides CM staff development opportunities for new skill acquisition. The CV works with the Sr. Director, Clinical Vet, Managers, and Shared Resources Administration to ensure that CM is providing effective and efficient products and services to its users.

Classification:

The Clinical Veterinarian is classified as essential personnel and, as such, is required to work with minimal amount of absences and during all Center closures except in the event of a major disaster when access to animal housing and use facilities is prohibited by governmental emergency personnel.

Primary job duties:

• Ensure medical and surgical care is maintained at the highest achievable level for all species
• Perform or oversee experimental procedures. Work with investigators to identify and/or refine procedures during experimental and/or IACUC protocol development to ensure minimal stress, discomfort and invasiveness while achieving experimental goals. Work with investigators to define appropriate and clear humane end points. Provide training and resources to investigators as required/ requested to ensure appropriate animal use and handling. Train investigative staff in novel veterinary procedures as needed.
• Oversee the selection, transport and acclimation of experimentally appropriate research animals to minimize experimental confounds and stressors. Provide appropriate environmental enrichment with the goal of improving the overall quality of the research.
• Participate in oversight of the rodent biosecurity program
• In conjunction with the Clinical Vet staff, oversee the adoption program including selection of animals, screening of potential adopters, proper documentation, and medical care in accordance with the adoption guidelines
• Coordinate with veterinary staff to ensure appropriate medical coverage for all laboratory animals at all times including after hours, weekends, vacations, and holidays.
• Maintain a fair and open dialogue with managers, supervisors, and staff. Provide performance feedback to the Sr. Director regarding performance of managers, supervisors, leads and technicians on a regular basis and not less than annually. Work with Clinical Vet and Technician Manager to provide performance feedback to Technicians on a regular basis and not less than annually.
• Provide and oversee appropriate continuing education and development for animal technicians as directed by the Sr. Director.  
• Ensure efficient research throughput by coordinating transfer of animals and other required medical and husbandry components between housing areas to accommodate increased research capacity.
• Work in conjunction with other CM management personnel to maintain open lines of communication related to resource use, quality and efficiencies.
• Provide a safe and positive work environment, working with EH&S, Occupational Health, Human Resources, and any other institutional entities as needed.
• Attend IACUC meetings as requested by the Sr. Director, CM and provide input regarding protocol development and review and other programmatic issues. Assist with animal facility inspections and follow up as needed or requested by the committee.
• Provide post-approval protocol monitoring, address potential noncompliance issues preemptively and work with the Principal Investigator, laboratory staff and IACUC office should issues of protocol violation occur.
• Maintain familiarity with existing federal regulations (AWA and PHS) and governing guidelines for accreditation, including “The Guide”, AVMA where applicable, ARENA, DEA, OSHA, etc... Understand the dynamic nature of the field and stay current with any changes to the regulations.
• In conjunction with support staff, provide assurance that electronic medical record training is provided for all appropriate technicians to maintain veterinary medical records in compliance with federal regulations and institutional standards.
• Keep current in the field by maintaining contacts with colleagues, attending relevant conferences and training sessions.
• Must be available for on-call weekends, holidays, and evenings on a rotating basis with other Comparative Medicine veterinarians.
• Undertake any other activities performed with the agreement of the Comparative Medicine Unit Sr. Director or named alternate on behalf of the Fred Hutch.

Qualifications

Minimum qualifications:

• Must have a DVM or VMD degree from an AVMA accredited veterinary school and be licensed or eligible for licensure to practice veterinary medicine in Washington State
• Be certified or eligible for certification as a Diplomat of the American College of Laboratory Animal Medicine
• Must have demonstrable clinical experience in rodent and canine medicine and surgery
• Must be academically oriented and able to understand and participate effectively in an active research environment
• Must be available to work after hours and on weekends
• Must have some understanding regarding the principles of biosafety, radiation safety, chemical safety, and physical safety as they pertain to animal facility operations
• Strong organizational skills and written/verbal communication skills, attention to detail and accuracy, and ability to work as a team member in an active and competitive biomedical research environment
• Must have or obtain within 6 months USDA accreditation Category 1 or 2  

Preferred qualifications:

• Have an advanced research oriented degree (i.e. M.S. and/or Ph.D) or residency training in a recognized program

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

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

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 GMP Materials Specialist in the Cell Processing Facility (CPF) is to maintain and execute materials control and product logistics within the cGMP environment. The Specialist supports the control and movement of raw materials and finished goods for manufacturing. The CPF is a clinical Phase I/II manufacturing facility within the Fred Hutch, which produces products for patients participating in clinical protocols using cellular therapy.

Responsibilities

• Follow and maintain the workflows of manufacturing Materials Control such as receipt and inspection, identification, quarantine, release, storage, and issuance of GMP materials used in production
• Administrate final product shipping/distribution to our customers
• Support monitoring of inventory, ordering and handling of supplies needed for operations
• Follow Standard Operating Procedures (SOPs) and complete required processing documentation such as on logbooks
• 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
• Identify issues, work collaboratively with the team to problem solve
• Identify deviations from approved policies and procedures. Document deviation, assist in the investigations, and assist in the development of 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

Qualifications

Required:

• Bachelor’s degree or three or more years of experience in materials management or inventory control in a cGMP environment
• Basic computer literacy and proficiency with standard computer programs (MS Office)
• Must be able to work efficiently, with strong attention to detail in a highly regulated environment
• Must be able to support teamwork and communicate effectively in a diverse team environment
• Set an example in support of teamwork within the manufacturing group
• 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)
• Meets physical requirements of the job, as follows: can lift a minimum of 40 pounds with or without assistance of tandem lift or other materials handling equipment, and the ability to bend, reach, stretch, and climb ladders
• Ability to work the occasional weekend days or evenings

Preferred:

• Experience writing or revising standard operating procedures, Materials Specifications, and other GMP Systems documentation
• Knowledge of lean manufacturing methodologies, such as Kanban
• Knowledge of 5S for warehousing organization

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

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

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 Genomics Specialist will work as part of a team to provide Genomics services to the Center's diverse research community. The incumbent will work under the direct supervision of the Genomics Resource Manager and will support day-to-day operation of the facility.

Responsibilities

• Provide technical expertise to support all services pertaining to NextGen sequencing and High Throughput Screening (HTS) laboratory operations
• Maintain a deep understanding of the technologies used in the Resource and provide advice and support to researchers on troubleshooting issues
• Support researcher activities for a wide variety of cell-based library generation processes (e.g., 10X Genomics, Auto Cut&Run, compound screens)
• Implement new methodologies and services to support existing NextGen services
• Have a mastery of molecular biology techniques pertaining to genomics-based technologies and be able to explain them to others
• Efficiently manage projects by organizing and multi-tasking
• Maintain a highly professional demeanor with researchers and associates
• Maintain accurate documentation of laboratory activities
• Support additional resource activities (e.g., capillary-based sequencing, NGS and library production processes) when needed

Qualifications

• Must have the knowledge and skill-base typically acquired through the completion of an undergraduate degree in Molecular Biology, Genetics, or related field
• Minimum of 5 years of professional laboratory experience including functional molecular biology work
• Experience with mammalian cell culture and processing to support downstream cell-based genomics platforms (preferred)
• Candidate should have experience with liquid handling automation and a working knowledge of genomics-based instrumentation and techniques
• Strong interpersonal and organizational skills are essential.

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

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

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 Lab Technician/Operator provides flow cytometry services to Center and external laboratories. The incumbent reports to the Flow Cytometry Director and works independently in performing daily responsibilities according to established procedures.

Responsibilities

• Maintain, calibrate and operate the flow cytometers to meet established performance and safety standards
• Perform periodic and as needed instrument maintenance
• Run samples for investigators as requested
• Instruct investigators in the proper use of equipment, data collection and analysis, providing individual assistance as necessary
• Provide researchers advice in panel design and experimental troubleshooting
• Maintain accurate department records including instrument use logs, materials used, supply inventories, capital equipment lists, equipment maintenance lists, department purchases and accounting records
• Prepare instrument billing for flow cytometry facility use
• Maintain current knowledge of advances in flow cytometry and recommend improved laboratory equipment as necessary
• Maintain current knowledge of laboratory data collection and analysis and recommend updated software and equipment as necessary
• Perform other responsibilities as required

Qualifications

• Bachelor’s degree in a physical or biological science required at the Lab Technician level. As an Operator, equivalent work experience is acceptable in lieu of degree. 
• Familiarity with or experience in optical systems, instrument analysis, computers or molecular and cell biology strongly desired.
• Must have experience working with flow cytometry either as a researcher using instrumentation or in a core facility/service roll to qualify for the Lab Technician role. This is experience is preferred but not necessary as an Operator.
• Demonstrated skill in working with electronics and machinery.
• Strong interpersonal and communication skills.

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

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

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 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

• Support the GMP cell therapy and biologics manufacturing operations as the responsible person for Quality systems
• Oversee self-auditing program to assure continual compliance with FACT standards and clinical regulatory requirements
• Ensure that the change management process related to manufacturing and analytical methods are evaluated and implemented to meet GMP and internal standards
• Manage the supplier/vendor qualification process in support of GMP activities
• Manage the Deviation/CAPA process to insure 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
• Provide support in review of specification and test methods
• Oversee routine quality management review and KPI assessments
• Oversee compliance to the training program requirements

Qualifications

• Bachelor of Science degree required in a scientific discipline including pharmaceutical, biologics, or related field
• At least 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

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

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

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 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

• Support the GMP cell therapy and biologics manufacturing operations as the responsible person for Quality systems
• Oversee self-auditing program to assure continual compliance with FACT standards and clinical regulatory requirements
• Ensure that the change management process related to manufacturing and analytical methods are evaluated and implemented to meet GMP and internal standards
• Manage the supplier/vendor qualification process in support of GMP activities
• Manage the Deviation/CAPA process to insure 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
• Provide support in review of specification and test methods
• Oversee routine quality management review and KPI assessments
• Oversee compliance to the training program requirements

Qualifications

• Bachelor of Science degree required in a scientific discipline including pharmaceutical, biologics, or related field
• At least 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

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

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

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 laboratory is recruiting a research histotechnologist to provide customized histology support for Fred Hutch research efforts. The histotech will assist with the design of innovative specimen preparation and staining protocols in a customer service based, team-oriented work environment. The histotech will support the lab in all aspects of the operations, including maintaining workflow and lab operations and assist in specimen preparation and equipment maintenance.

Responsibilities

• Verify specimen type and ID, accession specimens, and label slides and cassettes (using both automated and non-automated system)
• Understand, safely use, recycle, dispose of and store (in appropriate flammable cupboards) all histology reagents and supplies
• Understand and communicate basic science, research histology, pathology, and medical terminology with lab members, scientific researchers, and medical community
• Organize and track specimens, histology slides, paraffin and OCT blocks
• Gross and fix tissues in correct fixative (formalin, Methacarn, Carnoy’s and Paxgene)
• Cut paraffin and frozen blocks (sections) and curls for staining (basic and customized stainings including ISH, mFISH, LCM, Nanostring, Proteomics and other downstream analyzes e.g. Spatial transcriptomics)
• Perform manual and automated hematoxylin and eosin staining and basic special stains
• Understand theories and concepts of antibodies and immunohistochemistry and other detection methods
• Perform basic imaging and image management
• Accurately operate all histology equipment
• Assist in tissue array and/or tissue microarray (TMA) construction (manual, semi-auto or automated systems)
• Basic clerical/administration including but not limited to billing, filing, retrieving information on antibodies and histology stains, emailing and tracking projects using project management software
• Inventory, maintain, and order supplies, as necessary
• Preventative maintenance and cleaning of all histology equipment and including microscopes, microtome, cryostat, tissue processor, tissue stainers, freezers, and other histology equipment
• Participate in group meetings with laboratory staff and researchers
• Help with process improvement
• Perform other duties, as assigned

Qualifications

The minimum requirement is a bachelor’s degree and/or HT/HTL certification by a nationally recognized certifying agency, such as the American Society of Clinical Pathology is required. Relevant experience with basic histology is essential and experience with immunohistochemistry is also a plus.

The successful technologist must be able to work accurately and efficiently, be detail-oriented, and work both independently and within a group. Good troubleshooting and problem-solving skills are required. This position requires excellent written and verbal communication skills and the ability to work positively in a customer -oriented environment. In addition, the histotech in this position must be flexible and skilled at organizing and prioritizing tasks. Proficiency with Microsoft Word, Excel, and Internet Explorer, and digital pathology is essential.

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

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

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.

Fred Hutch is seeking a Senior Director, Clinical Manufacturing and Resources. This program includes GMP manufacturing of clinical grade cellular and biological products and resources supporting a wide variety of clinical trials.  Clinical manufacturing includes Cell Processing, Biologics Production, Quality Assurance, Quality Control, and Process Development.  Clinical Resources include Immune Monitoring and Specimen Processing. The Senior Director will manage operations and ensure the success of these critical clinical research resources. 

Responsibilities

The Sr. Director will have operational/financial oversight of seven core resources, including Cell Processing Facility, Biologics Production Facility, Quality Assurance, Quality Control, Process Development, Immune Monitoring and Specimen Processing.  The Sr. Director will be responsible for the efficient production and quality of both research and clinical-grade cellular and biological products and appropriate processing of clinical samples to serve and anticipate customer needs.  The Sr. Director reports to the Vice President, Interdisciplinary Science Administration.

Specific responsibilities include:

Leadership

• Responsible for performance and support of five resource Directors. The Sr. Director will promote continuous development of a team of manufacturing and quality professionals. 
• Lead strategic planning and develop and optimize plans for staffing, plant operations, and finance that support strategic goals and ensure compliance with FDA and GMP regulations.
• The Director will report to faculty advisory committees on a recurring basis concerning current operations, finance, and future needs and plans for the facility.

Financial management and Business Development

• Responsible for operating and capital budgets in collaboration with central Shared Resources administration
• Develop and maintain appropriate rate structures, conduct yearly reviews of rates, and ensure timely and appropriate billing in all resources.
• Assess new program opportunities and ensure robust support and collaboration with external and alliance partners.

Operations

• Develop and implement the overall strategy, priorities, and quality vision. Responsible for management of physical plant, operations, and data systems.
• Ensure coordination of production scheduling, project planning and quality program structure in collaboration with the core Directors.
• Assess needs and potential to expand services in response to end user needs.
• Ensure appropriate Quality Systems are maintained, including ongoing data analysis of product and process outputs to ensure early detection of quality issues and response to quality improvement opportunities.

Customer Service

• Collaborate with all users of clinical resources to ensure the highest possible quality in the facility, assess needs for operational changes, and anticipate and plan for future operational requirements.

Qualifications

• A Bachelor’s Degree (Master’s Degree or PhD preferred) with at least 5 years of experience in GMP manufacturing in a senior management role. 

• The candidate will have at least 5 years professional experience managing senior level personnel.  Strong leadership skills are required to lead clinical resources through periods of growth, change and time pressure. The ideal candidate will have a demonstrated ability to:

  • effectively lead individual teams as well as act collaboratively across an organization;

  • establish timelines, benchmark accountability and oversee program and project budgets;

  • develop and document procedures through strong project management skills and excellent written and verbal communication skills;

  • analyze data and apply an analytical framework to decision making.

• A high level of knowledge of cGMP and FDA requirements and guidance documents and a thorough understanding of quality systems is preferred, as is prior experience in managing inspections performed by the FDA and other regulatory authorities.
• Experience in the manufacturing of Cellular Therapeutic or Biological products is preferred. 

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

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

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.

Working under the direction of the Process Development (PD) Director within the Therapeutic Products Program (TPP), the 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 processes for early phase clinical trials as well as late stage development programs that may eventually lead to commercialization. Long term objectives are to develop efficient, cost-effective, and scalable processes so that these life-saving therapies can brought to patients in need.

Responsibilities

The Senior Process Development Associate will:

• Provide technical expertise for the PD department in the design and analysis of experiments and in presenting resultant data to groups outside of the department in a succinct, well-organized and coherent manner
• Identify opportunities for process improvements and champion their successful implementation
• Partner with investigators in the development of processes that will meet their clinical requirements and address constraints associated with larger-scale manufacturing
• Coordinate with project management and project sponsors to define the scope of development projects, including cost estimates and timelines
• Partner with GMP manufacturing staff to ensure appropriate transfer of needed process and analytical information for successful clinical material production
• Use strong communication and teamwork skills to build relationships with stakeholders (e.g., faculty, research staff, GMP manufacturing associates, etc.)

Qualifications

• BS in immunology, biology, chemical engineering or related scientific field
• 5+ years of experience in process development
• Direct experience in a process development environment supporting aseptic cell culture based manufacturing operations including 2+ years hands-on experience with B-cell/T-cell/stem cell isolation and expansion protocols
• Experience with primary cells (e.g., T cells, B cells, stem cells, etc.) and their isolation from primary sources, such as tissue and apheresis (e.g., CliniMACs)
• Knowledge of analytical methods to characterize processes including cell-based assays, flow cytometry, and proteomic/genomic methods; prior development/optimization of these methods highly preferred
• Familiar with the resolution of issues associated with process scale-up and transfer into a GMP manufacturing environment
• Experience with design of experiment (DOE) fundamentals and resultant data analysis
• 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
• 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.)

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

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

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.   

Responsibilities

The Veterinary Technician (VT) is responsible for:

• Performing routine husbandry, housekeeping, and skilled veterinary technical duties necessary for adequate care and support of research animals and facilities
• The position performs technical duties of animal care and veterinary support requiring knowledge of contamination, disease processes and biohazard containment
• May be assigned to train on and operate specialized equipment and to perform specialized procedures
• May be assigned work on or assist on animal manipulation segments of research protocols
• The VT reports directly to the Animal Facility Manager and may be expected to assist with animal care and husbandry duties in the CM small animal facility

The VT is classified as essential personnel and, as such, is required to work with minimal amount of absences and during all Center closures except in the event of a major disaster when access to animal housing and use facilities is prohibited by governmental emergency personnel. This is an as needed, part-time hourly position.

Qualifications

• Bachelor's Degree or License Veterinary Technician (LVT) credentials or strong science and animal husbandry background, preferred
• Minimum 1 -2 years of experience working with animals in a veterinary office
• Ability to perform animal care and custodial duties independently
• Ability to perform preventative animal health care and technical duties under the oversight of a VT Lead and the supervision of the Animal Facility Manager
• Flexibility in adjusting work schedule to complete needed tasks and or duties for absent technicians
• Ability to lift and move 50lbs on a regular basis and sustained activities such as: bending, balancing, stooping, reaching and remain standing for long periods of time
• Maintenance of a valid Washington State Driver's License and good driving record

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

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

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 Veterinary Technician Manager is responsible for oversight of the day-to-day operations of all veterinary technicians and veterinary technician leads in Comparative Medicine inclusive of large and small animal programs. This role ensures appropriate provision of veterinary technical care for resident animals, support for on-going research and availability of training for staff and researchers. The position directly assists the Veterinary staff in compliance with all applicable animal welfare regulations and policies.

 
The Veterinary Technician Manager reports directly to the Clinical Veterinarian and has the Veterinary Technician Leads, and the Veterinary Technicians as direct reports.

The Veterinary Technician Manager works independently in performing job assignments and uses judgment in technical animal care activities with minimal direction from clinical veterinarians. Directs the work of the staff and allocates the resources of the program to meet the needs of the research projects. This position is responsible for ensuring completion of critical animal care functions in compliance with regulatory obligations and coordinating alternative arrangements for completion of necessary duties when needed including Center closures.

Classification

The Veterinary Technician Manager is classified as essential personnel and, as such, is required to work with minimal amount of absences and during all Center closures except in the event of a major disaster when access to animal housing and use facilities is prohibited by governmental emergency personnel.

Responsibilities

• Supervise and assign duties to Veterinary Technician Leads, and in coordination with Veterinary Technician Leads, supervise and assign duties to Veterinary Set priorities, plan schedules to ensure full coverage of all animal facilities with regards to veterinary care, health monitoring, and research or other technical support
• Identify staffing needs. Interview, select, discipline, evaluate, promote, and motivate staff. Coordinate training and development of Conduct regular employee performance reviews and evaluations
• Work with Human Resources, Comparative Medicine Clinical Veterinarians and Sr. Director, and Shared Resources Administration to clearly define staff roles, career paths, and to create clear and appropriate staff
• Interact with investigators and research technicians to meet their animal care and service needs. Answer questions regarding policies and procedures, respond to complaints and review investigator requests for services for clarity, insuring technicians' completion of assignments according to instructions
• Keep informed of current animal welfare legislation and guidelines and monitor, along with veterinary technicians and CM Operations Staff all animal care areas to assure compliance with established standards. Review and update Standard Operating Procedures/ Policies/ Guidelines annually and create new ones as required
• Complete and submit a variety of administrative reports, assuring accuracy of record keeping and data collection and maintain computerized animal health
• Oversee maintenance of animal equipment such as anesthesia machines, facilities, and supply inventories, submitting maintenance requests and purchasing orders as needed
• Oversee organization and maintenance all aspects of the necropsy, treatment and surgical facilities, including equipment, drug inventories, packs, and cleaning
• Assist with surgical procedures and assist investigators with a variety of technical duties associated with research
• Monitor animal treatment records, ensure that all treatment regimens are carried out, observe treated animals daily, communicate changes in condition or complications to veterinarian, route paperwork appropriately and maintain file of animals
• Inform investigators of animal health status, obtain permission to treat when necessary and refer animal health reports and investigator questions
• Interact with diagnostic support laboratories to coordinate sample submission and ensure timely return and recording
• Assist in the proper conduct of the quality assurance programs for existing colonies of all animals housed on site, including evaluations for disease and genetic
• Schedule and assist veterinarians and other pertinent members of CM in creating staff training. Ensure that all training is current and up to date. Review and update all training material annually and conduct training as required
• Provide a safe as well as positive work environment, working with Environmental Health and Safety, Occupational Health, Ergonomics, Human Resources, and other institutional entities as required
• Participate and assist in monitoring legend and controlled substances inventory and use tracking
• Familiarize self with operations of major equipment within Comparative Medicine including LINAC, anesthesia machines and ventilators, and other relevant systems
• Coordinate the transportation and shipment of the animals, inspecting them for acceptability and appropriateness of the transport means, assisting with diagnostic evaluations and veterinary evaluations of the animals as needed, and maintain the separation from other animals as required by SOP’s. Assist in the development and revision of transportation and shipment SOP’s as required
• Work with the Veterinary Staff to deploy resources as necessary throughout the day to ensure effective and safe operations at the facilities including assistance with other components of Comparative Medicine such as Specialized Mouse Services, Comparative Pathology, the Preclinical Model Core and/or Animal Imaging
• Work with Shared Resources Administration and others to facilitate on-going maintenance, capital project work, and to provide data for billing and accounting purposes
• Interact with vendors to discuss improvements in products or identify solutions to any problems with equipment
• Work with Shared Resources Administration and Clinical Vets/ Sr. Director to lead tours of the facility
• May transport or assist in the transport of animals, supplies, or equipment between facilities
• May assist Veterinary Technicians if needed to meet animal care requirements
• Perform other duties as assigned

Qualifications

Minimum qualifications

• A Bachelor of Sciences degree in a medical, biological or allied field
• Minimum of five years of relevant veterinary experience
• Minimum of three years of relevant supervisory and managerial experience
• Excellent leadership and management skills with demonstrated ability to lead a diverse group of individual performers in delivering services
• Demonstrated understanding of federal and institutional animal welfare laws and policies, with experience in a laboratory animal setting
• AALAS laboratory animal technician certification, with preference given to candidates who are certified at the LATg level and/or CMAR
• Excellent verbal and written communication skills
• Excellent computer skills
• Ability to work in a fast-paced, demanding environment and master new skill sets quickly
• Commitment to promote and support a collegial and supportive work environment for all staff

Preferred qualifications

• Licensed veterinary technician or eligible for LVT credentialing
• Familiarity with IACUC procedures, understanding protocol implementation, and institutional responsibilities in this area
• Maintenance of a valid Washington State Driver’s License and good driving record

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