Director of Manufacturing, Biologics Processing Facility
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.
Working under the direction of the Sr. Administrative Director of the Therapeutic Products Program (TPP), the Director of Manufacturing for the Biologics Processing Facility (BPF) will define the overall strategy of the department, lead a diverse set of manufacturing associates and be responsible for the manufacture of cGMP clinical products for both internal and external partners. The Director will manage and oversee staff that utilize 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 plasmid vaccines.
The Biologics Processing Facility Director will provide direct technical and managerial leadership to the BPF group. The responsibilities of primary importance are to ensure the successful and time-sensitive GMP manufacture and release of clinical products, promote a culture of quality and compliance, and achieve continuous improvement. The position will involve managing manufacturing operations and the supervision of approximately 6 manufacturing staff. The successful applicant will interact on a daily basis with clinical trial sponsors, QA/QC, Process Development, research scientists, project management, and senior members of Fred Hutch faculty and administration.
Specific responsibilities include:
- Provide senior leadership for the BPF department including hiring of manufacturing staff and providing mentorship and staff development
- Use of strong communication and teamwork skills to build relationships with stakeholders
- Demonstrate outstanding technical acumen, operational understanding and cGMP compliance in the maintenance and continued expansion of the Biologics Processing Facility
- Lead the improvement and implementation of all cGMP procedures and policies related to manufacturing operations
- Insure the design, implementation and effectiveness of systems and processes that facilitate accurate and timely decision making and reporting.
- Focus on department performance and risk assessment/mitigation.
- Deliver results by meeting production schedules, improving process outputs, and improving operational efficiency and compliance. Maintain a high level of quality and safety standards.
- 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
- Foster a culture of strong GMP compliance
- Ensure all staff maintains appropriate level of training and meets compliance standards
- Establish and effectively manage project-specific and departmental annual operating budgets for the Biologics Processing Facility
- Evening and/or weekend work may occasionally be required based on project need
- Bachelor's degree in Biology, Chemistry, or related Science major. 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 or cell therapy manufacturing is required.
- Equivalent Laboratory Management experience is also acceptable in lieu of manufacturing experience.
- Ideal candidate will have experience running multi-product clinical biologics manufacturing operations concurrently.
- Has a thorough understanding of cGMP requirements for clinical manufacturing.
- Excellent communication skills, both oral and written.
- Writes and presents effectively; adjusts to fit the audience and the message; strongly gets a message across.
- Demonstrated leadership skills with excellent analytical and project management skills.
- Ability to evaluate technical data and write technical documents.
- Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
- 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).
May be required to travel on rare occasions for offsite training, customer meetings and technical transfer discussions.
An MS or PhD degree with equivalent professional or academic experienc
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