Lead Manufacturing Associate, Upstream

Avid Bioservices•Tustin, CA

6d•Onsite

About The Position

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 timely production and release of high-quality biopharmaceutical products. The position also leads improvement activities, supports training and development, and helps maintain inspection-ready operations and documentation. This is a full-time, on-site, non-exempt position working Wednesday through Saturday, four 10-hour days, with scheduled operating hours of 7:00 a.m. to 6:00 p.m. During initial training, the schedule is Monday through Friday from 7:00 a.m. to 4:00 p.m. The employee must be able to work overtime and/or additional weekends when necessary. The hourly compensation range is $31.92 to $39.90, depending on experience and qualifications. The role regularly involves sitting, speaking, hearing, using hands, standing, and walking in office and manufacturing environments. It may occasionally involve climbing, balancing, working in confined spaces, lifting up to 20 pounds, and using personal protective equipment. The environment may include electrical hazards, chemicals, vibration, airborne particles, wet or humid conditions, and elevated noise levels. Close, distance, and color vision are required. Reasonable accommodations are available.

Requirements

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.

Nice To Haves

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.

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.