Cell Processing Facility Supervisor

Job ID
18314
Type
Regular Full-Time
Company
Fred Hutchinson Cancer Research Center
Location
US-WA-Seattle
Category
Manufacturing

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. 

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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