Cellular Production Associate II-III
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
- Lead by example and take responsibility in the support of safety and cGMP compliance
- Represent manufacturing on cross-functional teams
Qualifications
- Bachelor’s degree in a biological science, or equivalent cGMP manufacturing bioprocessing experience
- A minimum of three years related postgraduate lab experience is required to qualify for the CPA II level with experience in production of cellular therapies and maintaining long-term T-cell lines/clones preferred. To qualify for the CPA III level, a minimum of 5 years of postgraduate experience related to process development and/or cGMP manufacturing is required.
- Mastery of open aseptic processing, working in biosafety cabinets
- Experience with cell culture. Establishing and maintaining long-term T-cell lines/clones preferred
- Experience writing or revising standard operating procedures, manufacturing batch records, and other GMP Systems documentation
- 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
- 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)
- 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.
Our Commitment to Diversity
We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.