Director Manufacturing Operations

Job ID
22199
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.   


Working under the direction of the Sr. Administrative Director of Therapeutic Products Program (TPP) Operations, the Director of TPP Ops Manufacturing will define the overall strategy of the core MFG group, with oversight of both the Biologics and Cell Processing Facilities (BPF and CPF).  These diverse teams are responsible for the manufacture of cGMP clinical products for both internal and external clients.  The TPP MFG Director will provide direct technical and managerial leadership to the MFG groups. The responsibilities of primary importance are to ensure the successful and time-sensitive GMP manufacture and release of clinical products, promoting a culture of quality and compliance, and achieving continuous improvement. The position will involve managing manufacturing operations and the supervision of approximately 25 manufacturing staff. The successful applicant will interact on a daily basis with clinical trial sponsors, QA/QC, Process Development, Process Engineering, research scientists, product management, and members of Fred Hutch faculty and administration.

 

The BPF performs development and cGMP manufacturing production utilizing technologies ranging from small-scale fermentation to mid-scale (130L) mammalian cell culture, protein purification and fill finish operations. The manufactured products include, but are not limited to, monoclonal antibodies, fusion proteins, viral vectors, and plasmids.

 

The CPF performs development and cGMP manufacturing production activities for cell therapy clinical trials involving the selection, genetic modification, and ex-vivo expansion of stem cells, T-cells, and B-cells.

Responsibilities

Specific responsibilities include:

  • Provide leadership for the MFG departments including hiring of manufacturing staff and providing mentorship and staff development
  • Foster a culture of excellence in building high performing teams
  • Ensure all staff maintain appropriate completion of required training
  • As a member of the TPP Leadership Team, contribute to strategic planning in the development of TPP goals and objectives, and work with the other directors in providing leadership to the department
  • Lead the improvement and implementation of all cGMP procedures and policies related to manufacturing operations
  • Ensure effective and efficient completion of compliance deliverables, such as deviation initiation, investigation, CAPA development and CAPA closure
  • Representing manufacturing in participation and response to audits and inspections
  • Ensure planning and utilization of plant capacity meets the needs for the expected deliverables. Analyze and evaluate the effectiveness of manufacturing methods, costs and results
  • Use of strong communication and teamwork skills to build high performing teams
  • Demonstrate outstanding technical acumen, operational understanding and cGMP compliance for clinical products
  • Ensure the design, implementation and effectiveness of operations systems and processes that facilitate safe, accurate and timely product delivery
  • As owner of the production facilities, utilities and equipment, ensure appropriate maintenance and operation
  • Provide oversight to the GMP Materials Control function
  • Ensure appropriate manufacturing execution readiness preparations, to set teams up for success
  • Deliver results by meeting production schedules, improving process outputs, and improving operational efficiency and compliance.  Maintain a high level of quality and safety standards

Qualifications

MINIMUM QUALIFICATIONS:

  • Bachelor's degree in Biology, Chemistry, or related Science field. Adequate experience in lieu of degree is acceptable
  • Hands on leader with minimum of 10 years supervisory experience and 7-10 years’ experience in leading and driving biologics and/or cell therapy manufacturing is required
  • Strong understanding of aseptic techniques, cell culture/cell expansion processing
  • Has a thorough understanding of cGMP requirements for clinical manufacturing, adept in the utilization of GMP systems
  • Experience as a manufacturing production facility owner
  • Demonstrated leadership skills and experience in personnel management
  • Excellent problem solving, analytical and project management skills
  • Ability to lead deviation response and root cause investigations, familiarity of FMEA methodology
  • Strong capability in guiding complex projects to effective and timely completion
  • Excellent communication skills, both oral and written. Writes and presents effectively
  • Strong customer service skills to interface effectively with internal and external clients
  • Ability to evaluate technical data and efficiently collaborate on, review and approve documents
  • Must be able to wear appropriate clean room attire and have the ability to wear surgical masks and all Personal Protective Equipment (PPE)
  • Evening and/or weekend work may occasionally be required based on project need


PREFERRED QUALIFICATIONS:

  • An MS or PhD degree in Immunology or related field
  • Experience with cell therapy processing operations and equipment
  • Experience running multi-product clinical biologics manufacturing operations

 


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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