Lead Manufacturing Associate, Upstream

Avid Bioservices; Tustin (CA); Presencial; USD 44.000 - 55.000; Jornada completa

Descripción de la vacante

Avid Bioservices, Inc. is seeking a Lead Manufacturing Associate, Upstream to provide hands-on leadership in a cGMP cell-culture facility. You will coordinate daily execution, guide upstream activities, and ensure timely production of high-quality biologics.

You will lead troubleshooting, training, and documentation, working with Wave bioreactors (100L-2000L) and DeltaV/MFCS systems, while ensuring compliance and readiness across the manufacturing floor.

Formación

• Bachelor's degree in a scientific field with 3–4 years related experience in upstream bioprocessing.
• Hands-on upstream cell-culture manufacturing in a cGMP environment.
• Experience with aseptic processing and controlled documentation.

Responsabilidades

• Lead upstream manufacturing activities including cell-bank thaw, expansion, bioreactor setup, feed additions, inoculation, harvest, and cGMP documentation.
• Perform aseptic processing under a biosafety cabinet with accurate execution and documentation.
• Operate and support Wave and 100L-2000L single-use bioreactors and associated control platforms.
• Coordinate daily work, priorities, and readiness to avoid delays in manufacturing.
• Troubleshoot equipment/process issues and escalate risks with recommended paths forward.
• Lead or contribute to manufacturing improvement projects and training; ensure batch production records are complete.

Conocimientos

Cell culture

cGMP experience

Aseptic processing

Equipment troubleshooting

Communication

Educación

Bachelor's degree in a related field

3–4 years related experience

Herramientas

Wave bioreactors 100L-2000L

DeltaV

MFCS

NOVA analyzers

Vi-CELL

pH meters

Centrifuges

Cytiva systems

Descripción del empleo

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 elevate 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 elevate 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:

This position regularly requires sitting, speaking, hearing, use of hands, standing, and walking in office and manufacturing environments. The role may occasionally require climbing, balancing, work in confined spaces, lifting up to 20 pounds, and use of personal protective equipment. The work 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 to enable individuals with differing abilities to perform the essential functions of the position.