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

Amneal

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. This position provides hands-on support, guidance, 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 role working 12-hour shifts from 7:00 PM to 7:00 AM EST on a 2-2-3 schedule to support 24/7 operations, including weekends and holidays. Initial training may take place on the day shift.

Requirements

High school diploma or equivalent required.
Five to seven or more 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 MS Word, Excel, and PowerPoint.
Strong communication and time-management skills.
Ability to work effectively with cross-functional teams.
Ability to work 12-hour shifts on a 2-2-3 schedule, including weekends and holidays.

Nice To Haves

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

Responsibilities

Supervise daily media and buffer preparation, cell culture operations, and associated cGMP documentation.
Coordinate and support mammalian cell culture activities, 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, and cell density/viability.
Oversee harvest activities, including depth filtration and material reconciliation for batch closure.
Ensure completion of equipment cleaning, verification, and status labeling.
Assist in troubleshooting upstream process or equipment issues and support investigations.
Provide on-the-job training to team members to support 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 preparation 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 material availability for scheduled operations.
Work with PD, QA, Analytical, Engineering, and Validation teams to support upstream manufacturing activities.
Support upstream technology transfer and scale-up activities, and assist with small projects and tech-transfer initiatives.
Ensure timely creation and follow-up of work orders for equipment issues.
Provide daily 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.
Health and insurance benefits.
401(k) matching contribution.
Employee well-being programs.

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