Associate Director, Process Development

Fred Hutchinson Cancer Center is an independent nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation HIV/AIDS prevention immunotherapy and COVID-19 vaccines Fred Hutch has earned a reputation as one of the worlds leading cancer infectious disease and biomedical research centers. 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 worlds deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration compassion determination excellence innovation integrity and respect. Our mission is directly tied to the humanity dignity and inherent value of each employee patient community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

The Fred Hutch Therapeutic Products Program (TPP) Process Development (PD) group supports cell processing manufacturing activities for early-stage clinical trials and performs technology advancement and development around cell therapy processes such as selection transduction and ex-vivo expansion parameters of stem cells T-cells and B-cells. The PD team works closely with internal Fred Hutch investigators and external collaborators to establish manufacturing processes for Phase I/II clinical trials. The long-term objectives are to develop efficient cost-effective and scalable processes so that these life-saving therapies are brought to patients in need.

Under the guidance of the Sr. Director Manufacturing Start-Up and the TPP Facility Director the Associate Director of Process Development provides technical expertise and coordination to the TPP Process Development group as well as serves 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 daily with Process Engineering Manufacturing Product Management QA/QC and very frequently clinical trial sponsors research scientists and senior Fred Hutch faculty and administration. This position requires significant expertise in the cell and gene therapy field as well as experience with team management and developing leadership skills.

At Fred Hutchinson Cancer Center all employees are expected to demonstrate a commitment to our values of collaboration compassion determination excellence innovation integrity and respect.

PRIMARY/ESSENTIAL DUTIES:

• Manage the daily activities of the Process Development (PD) team ensuring high-quality execution of development projects appropriate task delegation and alignment with broader TPP goals.
• Oversee and support a team of scientists and associates providing mentorship conducting performance reviews and fostering a culture of continuous learning and professional growth.
• Provide hands-on technical leadership in process design experimental planning execution and data analysis. Lead by hands on example in the lab when needed and support junior staff through scientific troubleshooting and training.
• Work with the TPP Facility Director on departmental planning by identifying future capability needs and innovation opportunities.
• Partner with internal teams including Product Management Process Engineering Manufacturing QA/QC and external investigators to define project scope ensure seamless tech transfer and enable clinical manufacturing.
• Maintain oversight of the PD lab space and equipment ensure safety and compliance and assist with capital equipment planning and resource allocation.
• Support the Sr. Director in resource planning budget development and timeline management. Track project pipelines adjust priorities as needed and ensure team workflows are organized well-communicated and aligned with institutional goals.
• Communicate results and project updates clearly to a range of stakeholders contribute to scientific presentations and publications and strengthen relationships across the institution and external collaborators.
• Other duties as assigned.

SCOPE OF RESPONSIBILITY:

• Level of autonomy
  
  • Assist Sr. Director in defining and implementing strategic objectives overall performance standards generating operational budgets and other guidelines for lab operations.
  • Assist TPP Facility Director in defining and implementing scientific and technical objectives for lab operations aligned with technology translation needs.
• Financial responsibility: This position has responsibility for financial decisions regarding Process Development including rate setting metrics and goals as delegated by Sr. Director.

MINIMUM QUALIFICATIONS:

• Ph. D. in Immunology Bioengineering Chemical Engineering Cell Biology or a related field.
• Minimum of 6 years of experience in process development for cell therapies including relevant GMP or translational work.
• At least 3 years of experience managing scientific staff leading technical teams or overseeing multi-project workflows.
• Direct hands-on experience with CAR-T or other engineered T-cell therapies including process optimization and/or tech transfer.
• Demonstrated ability to independently lead the design execution and troubleshooting of process development experiments using DOE principles and statistical tools (e.g. JMP).
• Knowledge of analytical methods to characterize processes including cell-based assays flow cytometry and proteomic/genomic methods.
• Familiarity with retroviral and/or lentiviral vector systems and viral transduction processes.
• Hands-on experience with both adherent and suspension cell cultures using flasks G-Rex and other culture vessels or bioreactors.
• Experience with downstream unit operations such as cell harvest operations cryopreservation and thaw recovery.
• Familiarity with cell processing equipment such as Miltenyi CliniMACS Prodigy LOVO and related tools.
• Demonstrated ability to lead process scale-up and transfer into GMP manufacturing environments.
• Proven ability to plan prioritize and execute across multiple concurrent development projects managing timelines scopes of work and resource allocation effectively.

PREFERRED QUALIFICATIONS:

• 8 years of experience in process development for cell therapies or biologics including work in GMP-regulated or clinical-stage environments.
• Experience with non-viral gene transfer processes such as CRISPR or base editing.
• Experience contributing to regulatory filings technical reports or peer-reviewed publications related to process development or cell therapy.
• Demonstrated success in mentoring and developing scientific staff and contributing to team growth and capability building.
• Experience with capital equipment planning budgeting processes or contributing to operational strategy.
• Skilled communicator with the ability to present technical strategies and data to senior leadership investigators or external collaborators.

The annual base salary range for this position is from $139464 to $232419 and pay offered will be based on experience and qualifications.

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health well-being and financial security. Benefits include medical/vision dental flexible spending accounts life disability retirement family life support employee assistance program onsite health clinic tuition reimbursement paid vacation (12-22 days per year) paid sick leave (12-25 days per year) paid holidays (13 days per year) and paid parental leave (up to 4 weeks).