GMP Cell Culture Manufacturing Lead

OPM Biosciences; Pleasanton (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

OPM Biosciences is seeking a highly experienced manufacturing leader to head GMP operations for cell culture media in Pleasanton, CA. The role focuses on aseptic processing, batch documentation, and compliance with ALCOA+ data integrity principles.

You will drive technology transfer from R&D to manufacturing, lead continuous improvement initiatives, and develop a skilled production team to meet quality and regulatory standards in a fast-paced biopharma environment.

Qualifications

• Degree in Biotechnology, Biochemical/ Chemical Engineering, Pharmaceutical Sciences, or related field.
• 5–10+ years of GMP manufacturing or biopharma production experience.
• Aseptic processing or media formulation experience at production scale.
• Strong knowledge of GMP systems, batch documentation, and regulatory expectations (FDA/EMA preferred).

Responsibilities

• Lead GMP manufacturing operations for cell culture media, including mixing, formulation, sterile filtration, and dispensing.
• Develop and execute SOPs, BMRs, and GMP production workflows.
• Support technology transfer from R&D to manufacturing and scale-up.
• Ensure compliance with GMP requirements, batch documentation standards, and ALCOA+ data integrity.
• Manage deviations, CAPA, and change control with QA/QC.
• Oversee production equipment operation, qualification, and maintenance support.
• Build, train, and develop the production team while driving operational excellence.

Skills

GMP manufacturing

Aseptic processing

Batch documentation

Data integrity(ALCOA+)

Team leadership

Education

Biotechnology/Engineering degree

Job description

OPM Biosciences is seeking a highly experienced manufacturing leader to head GMP operations for cell culture media in Pleasanton, CA. The role focuses on aseptic processing, batch documentation, and compliance with ALCOA+ data integrity principles.

You will drive technology transfer from R&D to manufacturing, lead continuous improvement initiatives, and develop a skilled production team to meet quality and regulatory standards in a fast-paced biopharma environment.