Cell Processing Facility Supervisor

Job ID
22353
Type
Regular Full-Time
Company
Fred Hutchinson Cancer Research Center
Location
US-WA-Seattle
Category
Manufacturing

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.   


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

  • Provides guidance when deviations arise from approved policies and procedures. Investigate and write deviation reports and develop CAPA.
  • Oversees and participates 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.
  • Evaluates 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.
  • Develops goals for direct reports on an annual basis and routinely monitor progress against those objectives. Conducts annual performance reviews of direct reports.
  • Works with manufacturing and technical staff to create, revise, and edit SOPs, batch records and raw material and product specifications as needed.
  • Reviews and approves 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 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.

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.

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