Senior Upstream Biologics Manufacturing Lead

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 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.