Supervisor, Manufacturing (Upstream) - 12-hour Night Shift

Amneal • Piscataway, NJ

6h • $90,000 - $110,000

About The Position

The Upstream Manufacturing Supervisor coordinates and supervises day-to-day mammalian cell culture operations in a cGMP biomanufacturing environment. The role supports seed train expansion, bioreactor operations, media and feed preparation, in-process monitoring, and execution of batch manufacturing records. The Supervisor ensures operational readiness, regulatory compliance, timely batch execution, and effective communication with cross-functional teams. The position provides hands-on support, guidance, training, and daily oversight to upstream manufacturing technicians and associates, while ensuring adherence to established processes and cGMP standards.

This is a full-time night-shift supervisor role on a 12-hour, 2-2-3 schedule supporting 24/7 manufacturing coverage, including weekends and holidays. Shift B runs from 7:00 PM to 7:00 AM EST; initial training may take place on the day shift. The position pays $90,000–$110,000 per year and offers a short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months. Eligible employees have access to a flexible benefits program, including health and insurance benefits and a 401(k) matching contribution.

Requirements

• High school diploma or equivalent.
• 5 to 7+ years of hands-on mammalian cell culture experience in biopharma or biotech manufacturing.
• Experience with single-use bioreactors, media preparation, aseptic techniques, and in-process sampling.
• Strong understanding of cGMP operations.
• Ability to troubleshoot and support upstream operational issues.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Strong communication and time-management skills.
• Ability to work effectively with cross-functional teams.
• Availability to work 12-hour night shifts on a 2-2-3 schedule, including weekends and holidays, to support 24/7 coverage.

Nice To Haves

• Bachelor’s or master’s degree in biology, biochemistry, biotechnology, or a related field.
• Commercial experience.

Responsibilities

• Supervise daily media and buffer preparation, cell culture operations, and associated cGMP documentation.
• Coordinate and support mammalian cell culture execution, including vial thaw, seed expansion, media fill, inoculation, harvest, and daily bioreactor monitoring.
• Ensure proper execution of aseptic operations under biosafety cabinets and use of single-use bioreactors up to 2000L.
• Review routine sampling activities and ensure timely in-process monitoring of pH, metabolites, cell density, and viability.
• Oversee harvest activities, including depth filtration and material reconciliation for batch closure.
• Ensure completion of equipment cleaning, verification, and status labeling.
• Assist with troubleshooting upstream process or equipment issues and support investigations.
• Provide on-the-job training to team members to promote process consistency and cGMP adherence.
• Review and ensure accurate completion of batch records, SOPs, protocols, and logbooks.
• Support deviation, CAPA, change-control, and investigation activities related to upstream operations.
• Participate in preparations for quality audits and regulatory inspections.
• Ensure daily operational compliance with cGMP, safety, and data-integrity standards.
• Monitor tracking, requesting, and staging of raw materials, media components, consumables, and gases.
• Ensure accurate label verification, receipt checks, and electronic inventory updates.
• Coordinate with warehouse and planning teams to ensure materials are available for scheduled operations.
• Work with PD, QA, Analytical, Engineering, and Validation teams to support upstream manufacturing.
• Support upstream technology transfer and scale-up activities and team participation in small projects and tech-transfer initiatives.
• Ensure timely creation and follow-up of work orders for equipment issues.
• Provide day-to-day direction, task assignments, coaching, and performance feedback to upstream operators.
• Support scheduling, shift coverage, and readiness for 24/7 operations as required.

Benefits

• Short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.
• Comprehensive, flexible benefits program for eligible positions.
• Health and insurance benefits.
• 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED