Sr. Manager, Manufacturing (Flex)

Avid Bioservices•Tustin, CA

2d•Onsite

About The Position

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. The Senior Manager, Manufacturing (Flex Shift) is the most senior manufacturing leader on site during the evening shift and is accountable for the safe, compliant, and efficient execution of GMP manufacturing operations across Upstream, Downstream, and Formulation functions. This role serves as the primary point of contact for all manufacturing-related escalations during the shift and is empowered to make real-time GMP decisions in alignment with Quality Assurance.

Requirements

Bachelor’s degree in a scientific, engineering, or related discipline; advanced degree preferred.
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.
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.
You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Nice To Haves

Advanced degree preferred.

Responsibilities

Provide overall leadership and oversight of all 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 arising during the shift.
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.