Director Process Development

Organization: Fred Hutch

Location: 
Seattle WA
US

Reporting to the Sr. Director of Therapeutics Products Program (TPP), the TPP Process Development (PD) group supports cell processing and manufacturing activities for early-stage cell therapy clinical trials, and performs technology advancement and development around selection, transduction, and ex-vivo expansion parameters of stem cells, T-cells, and B-cells.  PD works closely with internal Fred Hutch investigators and external collaborators to establish production processes for early phase clinical trials. Long term objectives are to develop efficient, cost-effective, and scalable processes so that these lifesaving therapies can be brought to patients in need.

The Process Development Director will provide technical and managerial leadership to the TPP Process Development group as well as serve as a technical and scientific resource for the entire TPP organization.  The position will ensure that development activities are well aligned with manufacturing needs, experiments are appropriately designed, and that results are effectively communicated to key stakeholders.  The successful applicant will interact on a daily basis with clinical trial sponsors, Process Engineering, Manufacturing, Product Management, QA/QC, research scientists, and senior Fred Hutch faculty and administration. 

Responsibilities

Specific responsibilities will include:

  • Provide technical expertise for the PD department in the design and analysis of experiments and in presenting resultant data to groups inside and outside of the department in a succinct, well-organized and coherent manner.
  • Ensure the appropriate management and maintenance of the PD laboratory facility and its equipment.
  • Provide senior leadership for the PD department including hiring and management of staff and providing mentorship and staff development
  • 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.
  • Partner with investigators in the development of processes that will meet their clinical requirements and address constraints associated with larger-scale manufacturing.
  • Coordinate with Product Management and project sponsors to define the scope of development projects, including cost estimates and timelines.
  • Partner with GMP Process Engineering and manufacturing staff to ensure appropriate transfer of needed processes and analytical information for successful clinical material production
  • Use strong communication and teamwork skills to build relationships with all stakeholders (e.g., faculty, research staff, GMP manufacturing, QA/QC etc.)
  • Provide input to the department annual operating budgets
  • Identify opportunities for process improvements and champion their successful implementation.
  • Publication of novel process improvements, meeting abstracts and/or talks, as appropriate.

Qualifications

MINIMUM QUALIFICATIONS:

  • Ph.D. in immunology, bioengineering, cellular biology, or related field
  • One or more years of GMP or GMP-related (e.g., process transfer, MFG audit response) experience
  • 7+ years of research experience in immunology, cell biology or related field that would support process development role
  • Experience as a personnel manager who has led/developed high performing teams.
  • Experience with design of experiment (DOE) fundamentals and resultant data analysis (e.g. JMP)
  • Experience with primary cells (e.g., T cells, B cells, stem cells, etc) and their isolation from primary sources, such as tissue and apheresis.
  • Familiarity with cell culture media development and optimization of cell culture processes and operating conditions
  • Familiarity with cell processing equipment such as Miltenyi CliniMACs or Prodigy, LOVO, cell counters, etc.
  • Knowledge of analytical methods to characterize processes including cell-based assays, flow cytometry, and proteomic/genomic methods.
  • Familiar with the resolution of issues associated with process scale-up and transfer into a GMP manufacturing environment
  • Ability to perform short- and long-term project planning in terms of the generation of scope of work documents and project plans, resource demands, timelines, and budget forecasting
  • Ability to prioritize multiple tasks, work under various timeline pressures, and drive tasks to completion
  • Strong collaboration, team-building, communication and organizational skills required.

PREFERRED QUALIFICATIONS:

  • 10+ years' experience in process development and supporting GMP cell culture based manufacturing operations. The ideal candidate will have experience in cell therapy applications with T-cells and stem cells; however, recognizing that this is a nascent field the candidate may have transferable skills from other biologics fields
  • Strong expertise in CAR-T cell therapy development and optimization
  • Experience working with adherent and suspension cell cultures in various flask, GRex and bioreactor systems (fed-batch/perfusion; fixed/disposable)
  • Experience with single use bioreactor systems and associated in-process analytical equipment.
  • Analytics method development and transfer.
  • Knowledge of retroviral or lentiviral vectors and transductions processes/systems.
  • Experience with cell culture associated unit operations such as tangential flow filtration for cell harvest/concentration, centrifugation, and cryopreservation/thaw recovery.

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

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.  

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 HR Operations at HRops@fredhutch.org or by calling 206-667-4700.

Not ready to apply? Connect with us for general consideration.
Minimum Education: 
Ph.D.