Senior Manufacturing Manager, Cell Processing Facility

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 world's 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 world's 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 Senior Manufacturing Manager, Cell Processing Facility, reporting to the TPP Senior Director, is responsible for leading the cGMP manufacturing team in the production of cellular and gene therapies in support of clinical research studies. The successful candidate will oversee the cGMP Cell Processing Facility (CPF) and address operational and routine challenges as they arise for Phase I/II clinical production. Knowledge of cell culture / aseptic operations / GMP manufacturing and support systems is essential. Demonstrated managerial skills and a strong working knowledge of the regulatory compliance requirements for the production of drug products used in clinical studies are essential.

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:

Oversees daily operations and staff (including production associates and supervisors) of cell therapy manufacturing for the on-time completion of products being manufactured.
• Assigns tasks to supervisors to ensure completion of daily and weekly manufacturing schedules.
• Participates in hiring, training, supervising and evaluating staff.
• Develops goals for direct reports on an annual basis and routinely monitors progress against those objectives. Conducts annual performance reviews of direct reports.
• Works closely with the production staff to troubleshoot process and equipment problems.
• Working with manufacturing and technical staff, creates, revises, and edits SOPs, batch records and raw material and product specifications as needed.
• Works closely with senior management to initiate new production projects and assists in developing processes/techniques to meet contract objectives.
• Manages cell manufacturing operations ensuring internal and external customer satisfaction and compliance with appropriate regulatory standards.
• Manages, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining facility standards.
• Executes against production schedule to meet customer and business goals.
• Provides accurate production forecasting methods with continuous improvement through capacity optimization and cost reduction programs.
• Ensures cGMP compliance, ensuring that all production equipment is properly validated and production processes meet quality standards.
• Interacts with customers on presentations and project results; will also work closely with customers during initial tech transfer activity and subsequent manufacturing campaigns.
• Other duties as assigned.

SCOPE OF RESPONSIBILITY:

• Level of automomy: Level of oversight includes ownership of CPF equipment, facility and utilities maintenance with staff which includes, Scheduler, Materials Control, Supervisors per shift, and MFG Associates on each shift.
• Financial Responsibility: Can make purchases under capital limit ($5000) for TPP CPF.

MINIMUM QUALIFICATIONS:

• Bachelor's degree in Biology, Chemistry, or related Science major required
• Minimum of 4 years supervisory experience and 7-10 years' experience in biologics or cell therapy manufacturing is required.
• Has a thorough understanding of cGMP requirements for clinical manufacturing.
• Experienced in oversight of Process Engineering functions such as process transfer, batch record development and creation and equipment onboarding and commissioning.
• Excellent communication skills, both oral and written.
• Demonstrated leadership 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 20 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).

PREFERRED QUALIFICATIONS:

• Direct experience in cell/gene therapy clinical manufacturing.

The annual base salary range for this position is from $137,259 to $216,923, 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), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).