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

Key Responsibilities

• Accurately weigh, measure, mix, and sterile filter cell culture media and buffer solutions within a cGMP environment
• Strictly follow cGMP, SOPs, company policies, and data integrity standards
• Execute batch records in real-time and maintain supporting documents/logbooks
• Conduct routine sampling, in-process testing, and daily in-process monitoring (pH, metabolites, cell density/viability)
• Use analytical equipment such as pH meter, conductivity meter, osmometer, and scales
• Perform equipment troubleshooting, cleaning, verification, and status labelling
• Coordinate investigations and corrections during batch execution
• Maintain good housekeeping and follow safety procedures including PPE use
• Write, revise, and execute manufacturing batch records, SOPs, protocols, and logbooks
• Assist with 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, receipt checks, and electronic inventory updates
• Coordinate with warehouse and planning teams for material readiness
• Collaborate with QA, Analytical, Engineering, and Validation groups
• Support technology transfer of new upstream processes or scale changes
• Generate work orders and follow up on machine breakdowns

Qualifications

Minimum Qualifications: High school diploma or equivalent required. Bachelor's degree preferred.

Preferred Qualifications: Experience in a manufacturing environment or 1-2 years of relevant experience preferred. Familiarity with safety protocols/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. Ability to communicate technical details at all levels, including senior leadership. Ability to troubleshoot technical issues and propose short- and long-term solutions. Strong time-management skills and the ability to work under demanding timelines.

Hands-on experience in biopharma or biotech manufacturing, or experience supporting cGMP operations and commercial exposure, is a plus. Experience with single-use bioreactors, media/buffer prep, aseptic operations, and in-process sampling. Strong technical skillset or understanding of cell culture and/or purification operations involved with mammalian cell manufacturing. Proficient in MS Word, Excel, PowerPoint, and basic statistical tools.

Additional Position Information

Manufacturing Operations is 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. Required Overtime (time-and-a-half pay), holidays, and weekends.

Work Environment & Physical Demands

Work in clean rooms and laboratories. Work at a desk doing computer work is also required. Protective eye gear required. Must be able to move around the facility to reach various equipment. Must be able to lift at least 25 lbs. to lift weights onto scale for daily scale verification. Must be able to stand for long periods of time. Frequent lifting/moving of approximately 25-50 lbs. Frequent transporting of approximately 100-250 lbs. buffer drums on casters with assistance. Occasional bending, squatting, kneeling, stooping, pushing, pulling, reaching, and walking.