GMP Manufacturing Lead – Cell Therapy & iPSC

Applied StemCell, Inc.; Milpitas (CA); On-site; USD 150,000 - 200,000; Full time

Job summary

Applied StemCell, Inc. in Milpitas, CA is seeking an experienced Manufacturing Manager with hands-on GMP operation experience to lead cell- and gene-therapy manufacturing efforts. The role combines scientific leadership with process optimization and compliance to cGMP.

You will oversee manufacturing operations, investigations, CAPAs, tech transfer, and cross-functional collaboration to drive quality, yield, and scalability for regulated products.

Qualifications

• Must have hands-on experience with GMP operations in regulated environments.
• Strong track record in cell-based drug product development and manufacturing.
• Proven ability to lead cross-functional teams and drive process improvements.
• Excellent troubleshooting and problem-solving abilities.

Responsibilities

• Serve as technical lead for GMP manufacturing of cell-based and biologic products.
• Provide leadership for manufacturing execution, process troubleshooting, and CAPA.
• Lead investigations of deviations, OOS results, and excursions; implement corrective actions.
• Support development activities to ensure robust, scalable manufacturing processes for clinical production.
• Collaborate with QA, Regulatory, and Tech Transfer during filings and inspections.

Skills

iPSC/stem cell culture

Genome engineering

Analytical skills

Communication skills

Education

PhD in Biology, Cell Biology, Developmental Biology, or related discipline

Job description

Applied StemCell, Inc. in Milpitas, CA is seeking an experienced Manufacturing Manager with hands-on GMP operation experience to lead cell- and gene-therapy manufacturing efforts. The role combines scientific leadership with process optimization and compliance to cGMP.

You will oversee manufacturing operations, investigations, CAPAs, tech transfer, and cross-functional collaboration to drive quality, yield, and scalability for regulated products.