Manufacturing Scientist

Stanford University • Palo Alto, CA

398d

About The Position

The Clinical Manufacturing Scientist (PDM3) at the Stanford Center for Cancer Cell Therapy (CCT) is responsible for providing specialized technical research and support in the manufacturing of clinical cell and gene therapies. This role involves leading biomanufacturing campaigns, ensuring compliance with Good Manufacturing Practice (cGMP), and overseeing the preparation of cellular products for clinical trials. The position requires collaboration with various functional teams and includes responsibilities for training staff, developing standard operating procedures, and maintaining data integrity.

Requirements

• Bachelor's degree in chemistry, microbiology, biological sciences, or related field with 4 years of experience, or a Master's degree with 2 years of experience.
• Experience with aseptic technique and cell culture.
• Strong preference for cGMP experience.
• Previous supervisory or management experience is desired.
• Experience with CAR T, TCR, T cells, gene editing, and cell and gene therapy process development/manufacturing is preferred.
• Knowledge of generating SOPs, batch records, and documentation for clinical manufacturing is preferred.
• Experience with tech transfer and engineering/qualification runs is a plus.

Nice To Haves

• Experience with following assays: cell culture, ELISA, tumor-killing assays, flow cytometry/CyTOF/FACS, qPCR/PCR, gene editing/CRISPR.
• Ability to occasionally work into the evening and/or on weekends.

Responsibilities

• Lead human clinical materials biomanufacturing campaigns as an operator or verifier.
• Prepare final formulated cellular products for cancer therapy clinical trials within production timelines.
• Oversee and coordinate junior staff in all activities related to manufacturing.
• Collaborate with functional teams including operations, regulatory affairs, and quality systems.
• Develop methods for manufacturing clinical materials according to cGMP standards.
• Develop standard operating procedures (SOPs), Batch Records, and product specifications.
• Critically assess experimental data and ensure data quality and integrity.
• Train and supervise Manufacturing Associates and Specialists.
• Manage day-to-day operations for functional areas of responsibility.
• Serve as a liaison to senior management and external organizations.

Benefits

• Health insurance
• Paid holidays
• Professional development opportunities
• Flexible scheduling

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Educational Services
• Education Level: Bachelor's degree