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Lead Manufacturing Associate, Upstream

Avid BioservicesTustin, California, United States

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: The Lead Manufacturing Associate, Upstream provides hands-on technical and frontline leadership for cGMP cell-culture manufacturing in a multi-product facility. The role supports supervisors by coordinating daily execution, communicating priorities, leading critical upstream activities, and helping resolve equipment and process issues. The Lead Manufacturing Associate serves as a liaison between management and manufacturing associates, promotes clear communication and readiness, and supports the timely production and release of high-quality biopharmaceutical products. This position also leads improvement activities, supports training and development, and helps maintain inspection-ready operations and documentation.

Key Responsibilities:

  • Lead critical upstream manufacturing activities, including cell-bank thaw, cell-culture expansion and maintenance, bioreactor setup, media and feed additions, inoculation, harvest, and associated cGMP documentation.
  • Perform aseptic processing under a biological safety cabinet and ensure accurate execution and documentation of cell-culture activities.
  • Operate and support Wave and 100L–2000L single-use bioreactors using applicable Cytiva, DeltaV, and MFCS systems.
  • Operate and support upstream process and analytical equipment, including NOVA analyzers, pH meters, Beckman Coulter Vi-CELL instruments, filtration systems, filter integrity testers, and centrifuges.
  • Coordinate daily work, priorities, and cross-functional readiness so the assigned team can execute manufacturing processes without unnecessary delay.
  • Lead floor-level troubleshooting of equipment and process issues, ensure timely escalation, recommend paths forward, and identify improvement opportunities.
  • Serve as a liaison between supervisors and manufacturing associates by communicating priorities, decisions, risks, and changes clearly and consistently.
  • Lead or contribute to manufacturing improvement activities involving SOPs, equipment and facility readiness, process and equipment efficiency, on-the-job training, and batch production records.
  • Review and support timely closure of upstream manufacturing records, helping ensure documentation is complete, accurate, and aligned with good documentation practices.
  • Support supervisors and technical specialists in developing future team leaders and process subject-matter experts.
  • Maintain required training and continue building technical and leadership capability while meeting assigned manufacturing responsibilities.
  • Perform other duties and related assignments consistent with the role’s purpose and level.

Minimum Qualifications:

  • Bachelor's degree from a four-year college or university and three to four years of related experience or training, or an equivalent combination of education and relevant experience.
  • At least two years of industry experience working with mammalian cell culture.
  • Hands-on experience executing upstream cell-culture manufacturing activities in a cGMP environment.
  • Experience with aseptic processing, bioreactor operations, equipment operation, and controlled manufacturing documentation.
  • Ability to coordinate work, communicate priorities, lead troubleshooting, and escalate risks appropriately in a manufacturing setting.

Preferred Qualifications:

  • Experience with single-use bioreactors at scales from 100L to 2000L and control platforms such as DeltaV or MFCS.
  • Experience with NOVA analyzers, Vi-CELL instruments, filter integrity testing, pod filtration, or centrifugation equipment.
  • Experience leading on-the-job training, manufacturing improvement projects, or shift-level coordination.
  • Working knowledge of SOP, batch production record, deviation, and good documentation practice requirements.

Position Type/Expected Hours of Work:

This is a full-time, on-site, non-exempt position with a Wednesday through Saturday schedule, working four 10-hour days. Scheduled operating hours are 7:00 a.m. to 6:00 p.m. During the initial training period, the schedule will be Monday through Friday from 7:00 a.m. to 4:00 p.m. The employee must also have the ability to work overtime and/or additional weekends when necessary.

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 $31.92 to $39.90 hourly 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:

  • You apply strong upstream manufacturing knowledge and model accurate, compliant execution on the manufacturing floor.
  • You coordinate work and communicate priorities clearly across manufacturing associates, supervisors, and partner functions.
  • You use sound judgment to troubleshoot routine equipment and process issues and escalate higher-risk conditions promptly.
  • You support team capability by sharing knowledge, reinforcing standard work, and helping develop future leaders and subject-matter experts.

Physical Demands & Work Environment:

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