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Leads evening-shift biologics manufacturing operations across upstream, downstream, and formulation functions. Oversees GMP compliance, real-time decision-making, deviation triage, batch documentation, shift handoffs, and coordination with QA, Engineering, Facilities, EHS, and Automation. Manages and coaches manufacturing supervisors, supports audits and inspections, and drives safety, quality, continuous improvement, and right-first-time execution. This is a full-time onsite role requiring flexibility for overtime, weekends, holidays, and extended operational support.
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.
Your Role:
Your Role:
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.
Key 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.
Minimum Qualifications:
- 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.
Position Type/Expected Hours of Work:
This role is a full-time onsite position in Tustin, CA. Days and hours of work are Monday through Friday, 1:00PM to 10:00PM unless otherwise stated by Supervisor. The employee must also, if instructed, have the ability to work overtime and/or weekends when necessary.
This position requires consistent on-site presence during the Flex shift and the ability to support extended hours, weekends, or holidays based on operational demands. The Senior Manager is expected to provide steady leadership, disciplined execution, and clear escalation management to ensure uninterrupted manufacturing operations during off-hours.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $139,200 - $174,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
Who you are:
- 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.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
Avid Bioservices Tustin, California, USA Office
14191 Myford Rd, Tustin, California, United States, 92780 7020
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