Senior Manufacturing Leader – Flex Shift (Biologics)

avidbio; Tustin (CA); On-site; USD 139,000 - 174,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices in California is seeking a Senior Manager, Manufacturing for the Flex shift to lead GMP operations across Upstream, Downstream, and Formulation. You will ensure safe, compliant, and efficient manufacturing and serve as the primary escalation point for shift issues.

You will coach Manufacturing Supervisors, review batch records, and coordinate with QA, Engineering, Facilities, EHS, and Automation to maintain uninterrupted operations on the 5:00 pm–2:00 am shift.

Qualifications

• 10+ years of experience in biologics or pharmaceutical GMP manufacturing, with leadership across multiple manufacturing functions.
• 5+ years of people management experience, including direct supervision of supervisors or managers.
• Strong working knowledge of Upstream, Downstream, and Formulation manufacturing processes.
• Demonstrated experience making real-time GMP decisions and leading deviation triage and containment.
• Thorough knowledge of FDA GMP regulations and industry best practices.
• Proven ability to lead cross-functional teams during non-standard hours and manage complex operational scenarios.
• Excellent communication, decision-making, and organizational skills in a fast-paced manufacturing environment.

Responsibilities

• Provide leadership of manufacturing operations across Upstream, Downstream, and Formulation during the Flex shift (5:00 pm – 2:00 am).
• Serve as the primary escalation point for manufacturing, quality, safety, and operational issues.
• Make real-time GMP decisions, including assessment of process deviations, execution concerns, and operational risks, in close alignment with Quality Assurance.
• Maintain strong on-the-floor presence during critical manufacturing activities to ensure adherence to approved procedures and real-time issue resolution.
• Directly manage and coach Manufacturing Supervisors across all functional areas, driving accountability, performance, and development.
• Lead immediate triage, containment, and documentation of deviations, ensuring high-quality shift handovers and continuity into subsequent investigations or CAPAs.
• Review executed batch records and manufacturing documentation for accuracy, completeness, and compliance prior to handoff to Quality.
• Coordinate with on-call and off-shift functions including QA, Engineering, Facilities, EHS, and Automation to ensure uninterrupted operations.
• Ensure effective shift turnover processes, including clear communication of operational status, risks, and upcoming critical activities.
• Drive right-first-time execution through active observation, coaching, and reinforcement of GMP behaviors on the manufacturing floor.
• Support off-hours audits, inspections, or client activities as required, serving as the manufacturing representative.
• Promote a culture of safety, quality, continuous improvement, and accountability across all teams during the Flex shift.

Skills

Biologics GMP

Leadership

Cross-functional collaboration

Communication

Decision-making

Education

Bachelor's degree in science/engineering

Advanced degree preferred

Job description

Avid Bioservices in California is seeking a Senior Manager, Manufacturing for the Flex shift to lead GMP operations across Upstream, Downstream, and Formulation. You will ensure safe, compliant, and efficient manufacturing and serve as the primary escalation point for shift issues.

You will coach Manufacturing Supervisors, review batch records, and coordinate with QA, Engineering, Facilities, EHS, and Automation to maintain uninterrupted operations on the 5:00 pm–2:00 am shift.