CPF Process Engineering Manager/Sr. Manager

Job ID
18499
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 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.

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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