Supervisor, Manufacturing (Upstream) - 12-hour Night Shift
hcfa.fa.us2.oraclecloud.com/KashivUSCareers · Piscataway, New Jersey, United States
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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Education
• High school diploma or equivalent required. Bachelor’s/master’s degree in biology, Biochemistry, Biotechnology, or related field preferred.
Preferred Experience
• 5 to 7 + years of hands-on experience with mammalian cell culture in biopharma or biotech manufacturing.
• Experience with single-use bioreactors, media preparation, aseptic techniques, and in-process sampling.
• Strong understanding of cGMP operations; commercial experience is a plus.
• Ability to troubleshoot and support upstream operational issues.
• Proficiency in MS Word, Excel, PowerPoint.
• Strong communication and time-management skills.
• Ability to work effectively with cross-functional teams.
Other requirements:
As a biologics/biosimilars company, our schedules are driven by process requirements.
Manufacturing Operations is for 12hr shifts for 24/7 coverage (2-2-3 work schedule), including holidays and weekends.
Shift B (night shift): 7:00 PM to 7:00 AM EST.
Initial training may be performed on the day shift
This position is for a full-time night shift supervisor.
The salary range for this position ranges from $90,000 - $110,000 per year. In addition, Kashiv BioSciences, LLC., offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months. Kashiv BioSciences, LLC., ranges reflect the Company’s good faith estimate of what Kashiv BioSciences, LLC., reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.
At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.