Biologics Manufacturing Senior Manager - Flex Shift

BioTalent; Tustin (CA); On-site; USD 139,000 - 157,000; Full time

Benefits offered by this job

On-site in Tustin, CA

Job summary

BioTalent Senior Manager, Manufacturing (Flex Shift) leads manufacturing operations across Upstream, Downstream and Formulation in a commercial biologics GMP setting in Tustin, CA. You will guide shift manufacturing, ensure safety and quality, and drive continuous improvement.

You will mentor Manufacturing Supervisors, make real-time GMP decisions, and partner with QA to resolve deviations, ensuring accurate batch documentation and regulatory compliance.

Qualifications

• 10+ years of experience in biologics or pharmaceutical GMP manufacturing with demonstrated leadership across multiple manufacturing functions
• 5+ years of people management experience, including direct supervision of supervisors or managers
• Thorough knowledge of Upstream, Downstream, and Formulation manufacturing processes
• Demonstrated experience making real-time GMP decisions and leading deviation triage and containment activities
• Thorough knowledge of FDA GMP regulations and industry best practices

Responsibilities

• Lead and oversee all manufacturing operations across Upstream, Downstream, and Formulation during the Flex Shift
• Serve as the primary escalation point for manufacturing, quality, safety, and operational issues
• Make real-time GMP decisions in partnership with Quality Assurance
• Drive execution, compliance, and issue resolution during critical manufacturing operations
• Lead deviation triage, containment activities, investigations, and shift handovers
• Directly manage and coach Manufacturing Supervisors across multiple functional areas
• Review batch records and manufacturing documentation to ensure accuracy and compliance
• Promote a culture of safety, quality, accountability, and continuous improvement across manufacturing teams

Skills

Leadership

GMP knowledge

Education

Bachelor's degree in science/engineering

Advanced degree preferred

Job description

BioTalent Senior Manager, Manufacturing (Flex Shift) leads manufacturing operations across Upstream, Downstream and Formulation in a commercial biologics GMP setting in Tustin, CA. You will guide shift manufacturing, ensure safety and quality, and drive continuous improvement.

You will mentor Manufacturing Supervisors, make real-time GMP decisions, and partner with QA to resolve deviations, ensuring accurate batch documentation and regulatory compliance.