Manufacturing Media & Buffer Prep Associate - 12-Hour Night Shift

Amneal India • Piscataway, NJ

5d • $25 - $30

About The Position

The Manufacturing Media & Buffer Prep Associate prepares cell culture media and buffer solutions in a cGMP manufacturing environment. The position involves weighing, measuring, mixing, and sterile filtering materials; performing routine sampling and in-process monitoring; using analytical equipment; troubleshooting, cleaning, verifying, and labeling equipment; and maintaining accurate, timely batch documentation. The associate follows cGMP, SOPs, safety procedures, and data-integrity standards, and supports investigations and corrections during batch execution.

The role also supports quality systems and compliance by writing, revising, and executing batch records, SOPs, protocols, and logbooks; assisting with deviations, CAPAs, change controls, and investigations; and supporting audits and regulatory inspections. Responsibilities include tracking and staging raw materials, verifying labels and receipts, updating electronic inventory, and coordinating material readiness with warehouse and planning teams.

The associate collaborates with QA, Analytical, Engineering, and Validation groups; supports technology transfers and manufacturing scale changes; contributes to projects; and generates and follows up on work orders for equipment breakdowns. Manufacturing operates on 12-hour shifts for 24/7 coverage on a 2-2-3 schedule. This is the night shift, 7:00 PM to 7:00 AM EST; initial training may occur on day shift. Required overtime, holiday, and weekend work applies.

Requirements

• High school diploma or equivalent.
• Ability to work in a team-oriented environment with cross-functional groups.
• Ability to work in a fast-paced environment and handle changing manufacturing demands.
• Excellent written and verbal communication skills, including the ability to communicate technical details at all levels.
• Ability to troubleshoot technical issues and propose short- and long-term solutions.
• Strong time-management skills and ability to work under demanding timelines.
• Ability to work a 12-hour shift on a 2-2-3 schedule supporting 24/7 operations, including required overtime, weekends, and holidays.
• Ability to work flexible hours as needed, under pressure, and to meet deadlines.
• Ability to work in clean rooms and laboratories and perform computer-based document work.
• Ability to move around the facility and reach equipment; stand for long periods; and perform occasional bending, squatting, kneeling, stooping, pushing, pulling, reaching, and walking.
• Ability to lift at least 25 lbs. and frequently lift or move approximately 25–50 lbs.; ability to frequently transport approximately 100–250 lb. buffer drums on casters with assistance.
• Use protective eye gear and comply with safety procedures.

Nice To Haves

• Bachelor’s degree.
• Manufacturing experience or 1–2 years of relevant experience.
• Familiarity with safety protocols and procedures.
• Hands-on experience in biopharma or biotech manufacturing, cGMP operations, or commercial operations.
• Experience with single-use bioreactors, media and buffer preparation, aseptic operations, and in-process sampling.
• Strong technical skillset or understanding of cell culture and/or purification operations involved in mammalian cell manufacturing.
• Proficiency in MS Word, Excel, PowerPoint, and basic statistical tools.

Responsibilities

• Accurately weigh, measure, mix, and sterile filter cell culture media and buffer solutions in a cGMP environment.
• Follow current Good Manufacturing Practices, SOPs, company policies, safety procedures, and data-integrity standards.
• Execute batch records and supporting documentation and logbooks in real time, maintaining accurate documentation and timely batch execution.
• Conduct routine sampling, support in-process testing, and perform daily in-process monitoring throughout batch duration, including pH, metabolites, and cell density or viability.
• Use analytical equipment such as pH meters, conductivity meters, osmometers, and scales.
• Troubleshoot, clean, verify, and status-label equipment.
• Use programs to collect, evaluate, and review operating data and make on-line adjustments to instruments or equipment.
• Interpret and provide instructions in written, oral, diagram, or scheduled formats.
• Coordinate and support investigations and corrections for issues arising during batch execution.
• Maintain good housekeeping in the work area and demonstrate dependable attendance and adherence to timelines and schedules.
• Perform other functions as required or assigned to support manufacturing operations.
• Write, revise, and execute manufacturing batch records, SOPs, protocols, and logbooks.
• Assist with opening and closing deviations, CAPAs, change controls, and investigations.
• Support quality audits and regulatory inspections.
• Track, request, and stage raw materials, including media components, consumables, and gases.
• Perform label verification and receipt checks and update electronic inventory.
• Coordinate material readiness with warehouse and planning teams.
• Collaborate with QA, Analytical, Engineering, and Validation groups.
• Support technology transfer of new upstream processes or scale changes.
• Perform small projects independently and contribute to larger technology-transfer initiatives.
• Generate work orders and follow up on machine breakdowns.
• Work required overtime and provide holiday and weekend coverage.
• Use required personal protective equipment and follow area-specific safety procedures.

Benefits

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

What This Job Offers

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