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

Kashiv US; Piscataway Township (NJ); On-site; USD 90,000 - 150,000; Full time

Job summary

Kashiv US is seeking an Upstream Manufacturing Supervisor to coordinate mammalian cell culture operations in a cGMP biomanufacturing environment. You will oversee media prep, seed expansion, bioreactor monitoring, aseptic practices, and batch documentation to ensure timely, compliant production.

Responsibilities include mentoring operators, maintaining quality records, supporting audits, and coordinating materials with storage and planning teams for continuous 24/7 operations.

Qualifications

• Hands-on supervision of upstream manufacturing technicians and associates.
• Experience in cGMP biomanufacturing environments is beneficial.
• Familiarity with batch records, SOPs, and deviation/CAPA processes.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.

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.

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.

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.

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.

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.