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

Amneal

5d

About The Position

The Manufacturing Media & Buffer Prep Associate prepares cell culture media and buffer solutions in a cGMP manufacturing environment. The role involves accurate weighing, measuring, mixing, and sterile filtration, along with real-time batch-record execution, sampling, in-process monitoring, equipment use and care, and compliance with safety, documentation, and data-integrity standards. The associate also supports investigations, materials management, audits, and technology transfers in collaboration with QA, Analytical, Engineering, Validation, warehouse, and planning teams.

This role works 12-hour night shifts, from 7:00 PM to 7:00 AM EST, on a 2-2-3 schedule to support 24/7 manufacturing operations. Weekend and holiday coverage and required overtime are part of the schedule. Initial training may take place on day shift. Work takes place in clean rooms and laboratories, as well as at a desk for computer and documentation tasks. The position involves standing for extended periods, moving around the facility, and frequent lifting and handling of materials.

Requirements

• High school diploma or equivalent required.
• Ability to follow safety protocols and procedures.
• 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.
• Availability for 12-hour night shifts on a 2-2-3 schedule, including weekends and holidays, and required overtime.
• Ability to work flexible hours as needed and under pressure to meet deadlines.
• Ability to travel if needed.
• Ability to lift at least 25 lbs., stand for long periods, and perform the physical tasks described for the role.
• Ability to work in clean rooms and laboratories and use protective eye gear.

Nice To Haves

• Bachelor’s degree preferred.
• Manufacturing environment experience or 1–2 years of relevant experience preferred.
• Hands-on experience in biopharma or biotech manufacturing, supporting cGMP operations, or commercial operations exposure.
• 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.
• Follow cGMP, SOPs, company policies, safety procedures, and data-integrity standards.
• Execute batch records in real time and maintain supporting documents and logbooks.
• Complete batches on time and maintain proper documentation practices.
• Conduct routine sampling, support in-process testing, and perform daily in-process monitoring, including pH, metabolites, and cell density/viability.
• Use analytical equipment such as pH meters, conductivity meters, osmometers, and scales.
• Troubleshoot, clean, verify, and label equipment status.
• Use programs to collect, evaluate, and review operating data and make on-line adjustments to instruments or equipment.
• Interpret written, oral, diagrammatic, or scheduled instructions and provide instructions as needed.
• Coordinate or support investigations and corrections for issues arising during batch execution.
• Maintain good housekeeping in the work area and follow applicable PPE requirements.
• 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, consumables, and gases; perform label verification, receipt checks, and electronic inventory updates.
• 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; independently perform small projects and contribute to larger initiatives.
• Generate work orders and follow up on machine breakdowns.
• Demonstrate dependable attendance and adherence to timelines and schedules; perform other functions as assigned to support manufacturing operations.

Benefits

• Short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.
• Comprehensive, flexible 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
• Education Level: High school or GED