Upstream Manufacturing Manager

Global Life Science Hub; San Jose (CA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Global Life Science Hub seeks an experienced Upstream Manufacturing Manager to lead commercial USP Drug Substance operations at a state-of-the-art biologics facility in California. The role focuses on mammalian cell culture, bioreactor operation, batch execution and compliance with GMP standards.

You will mentor Manufacturing Associates, coordinate daily activities, and work closely with Quality, Engineering and MSAT to drive continuous improvement and readiness for manufacturing campaigns.

Qualifications

• 8+ years of GMP biopharmaceutical manufacturing experience.
• Previous leadership or supervisory experience in biologics.
• Hands-on mammalian cell culture manufacturing experience.
• Experience with single-use bioreactors in commercial or late-stage environments.
• Familiarity with GMP docs, batch records, deviations and CAPAs.

Responsibilities

• Lead and supervise Manufacturing Associates in a GMP biologics facility.
• Oversee mammalian cell culture operations including bioreactors up to 2,000L.
• Support commercial manufacturing campaigns with single-use systems.
• Monitor critical process parameters to ensure successful batches.
• Ensure compliance with batch records, SOPs and GMP requirements.
• Review and approve manufacturing records and investigations.
• Coordinate daily manufacturing activities and shift priorities.
• Collaborate with Quality, Engineering, Validation and MSAT teams.
• Support process validation, tech transfer and readiness activities.

Skills

Leadership

Team coordination

Communication

Education

Bachelor's degree in Biology/Biotech/ Biochem/ Chemical Eng

Job description

Global Life Science Hub is partnered with a biopharmaceutical company that is expanding its commercial manufacturing capabilities following multiple product approvals and significant investment into manufacturing infrastructure.

To support this growth, we are seeking an experienced Upstream Manufacturing Manager to help lead commercial USP Drug Substance manufacturing operations at a state-of-the-art biologics facility in California.

With multiple commercial manufacturing suites and significant planned capacity growth, this is a rare opportunity to join a facility at a pivotal stage of its journey and play a key role in shaping the future of biologics manufacturing operations.

Responsibilities:

• Lead and supervise a team of Manufacturing Associates within a GMP biologics manufacturing environment.
• Oversee mammalian cell culture operations including media preparation, seed train expansion, inoculation, bioreactor operation, harvest and clarification.
• Support commercial manufacturing campaigns across single-use bioreactor systems up to 2,000L scale.
• Monitor and troubleshoot critical process parameters including pH, dissolved oxygen, temperature, agitation and gas flow rates to ensure successful batch execution.
• Ensure manufacturing activities are performed in accordance with batch records, SOPs and GMP requirements.
• Review and approve batch documentation, logbooks and manufacturing records to ensure compliance and right-first-time execution.
• Lead investigations related to deviations, process excursions and manufacturing events, driving timely resolution and corrective actions.
• Coordinate daily manufacturing activities, staffing and shift priorities to achieve production targets safely and efficiently.
• Partner with Quality, Engineering, Validation and MSAT teams to support manufacturing operations and continuous improvement initiatives.
• Support process validation, technology transfer and manufacturing readiness activities.
• Train, mentor and develop Manufacturing Associates while promoting a culture of safety, quality and operational excellence.

Experience/Qualifications:

• Bachelor's degree in Biology, Biotechnology, Biochemistry, Chemical Engineering or a related scientific discipline.
• 8+ years of GMP biopharmaceutical manufacturing experience.
• Previous leadership, lead operator or supervisory experience within biologics manufacturing.
• Hands-on experience supporting mammalian cell culture manufacturing operations.
• Experience operating single-use bioreactors within commercial or late-stage clinical manufacturing environments.
• Strong understanding of seed train expansion, cell culture processes, harvest and clarification operations.
• Experience reviewing GMP documentation, batch records and manufacturing investigations.
• Working knowledge of deviations, CAPAs, change controls and regulatory compliance requirements.
• Strong communication and leadership skills with the ability to lead teams in a fast-paced manufacturing environment.

Relocation assistance is available, and we welcome applications from candidates across the U.S. who are open to relocating.