Job Description

The Upstream Manufacturing Supervisor is responsible for coordinating and supervising day-to-day mammalian cell culture operations in a cGMP biomanufacturing environment. This role supports upstream production activities including seed train expansion, bioreactor operations, media and feed preparation, in-process monitoring, and execution of batch manufacturing records.
The Supervisor ensures operational readiness, compliance with regulatory requirements, timely execution of assigned batches, and effective communication with cross-functional teams. This role provides hands-on support, guidance, and daily oversight to upstream manufacturing technicians and associates while ensuring adherence to established processes and cGMP standards.
 

Upstream Process Operations Supervision
•    Supervise daily media and buffer preparation, Cell Culture operations, and associated cGMP documentation.
•    Coordinate and support execution of mammalian cell culture 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 (pH, metabolites, 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 investigation activities.
•    Provide on-the-job training to team members to ensure process consistency and cGMP adherence.
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QMS, Documentation & Compliance
•    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 activities for quality audits and regulatory inspections.
•    Ensure daily operational compliance with cGMP, safety, and data integrity standards.
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Material & Inventory Coordination
•    Monitor tracking, requesting, and staging of raw materials, media components, consumables, and gases.
•    Ensure label verification, receipt checks, and electronic inventory updates are completed accurately.
•    Coordinate with warehouse and planning teams to ensure material availability for scheduled operations.
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Cross-Functional & Technical Transfer Support
•    Work closely with PD, QA, Analytical, Engineering, and Validation teams to support upstream manufacturing activities.
•    Support upstream-related technology transfer and scale-up activities.
•    Assist team participation in small projects and tech-transfer initiatives.
•    Ensure timely creation and follow-up of work orders for equipment issues.
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Team Leadership
•    Provide day-to-day directions, task assignments, coaching, and performance feedback to upstream operators.
•    Support scheduling, shift coverage, and readiness for 24/7 operations as required.
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