Senior Manufacturing Manager, Cell Processing Facility

Overview

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.

Responsibilities

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.

Qualifications

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 bio