The MCS Manufacturing Associate in Cell Banking will support the Cell Banking Group contributing to the dynamic GMP-regulated production environment. The ideal candidate will have a Bachelor’s degree in Biology, Molecular Biology, or Biochemistry, and preferably pharmaceutical industry experience. However, candidates with strong lab skills, aseptic technique, and relevant experience from internships or cross-industry backgrounds will also be considered. This role involves hands-on operations, including cell culture, media batching, and cleaning biosafety cabinets, with an emphasis on following Standard Operating Procedures (SOPs) and adhering to Good Manufacturing Practices (GMPs).
Key Responsibilities:
Manufacturing Operations:
- Set up, clean, and sanitize manufacturing equipment.
- Prepare buffers and media according to defined Manufacturing Procedures (MPs) and SOPs.
- Perform and monitor critical processes, troubleshooting basic issues as they arise.
- Conduct in-process sampling and operate analytical equipment.
- Execute washroom activities, including cleaning both small- and large-scale equipment.
- Maintain an organized, clean, and compliant workspace.
Compliance & Safety:
- Strictly adhere to GMP regulations, SOPs, and MPs, ensuring compliance with safety and environmental protocols.
- Work in a cleanroom environment, adhering to full gowning requirements (steel-toe shoes, cleanroom suit, hairnet, gloves).
- Identify, recommend, and implement improvements for routine functions to enhance process efficiency.
- Review documentation such as batch records and equipment logs to ensure compliance.
Physical & Environmental Requirements:
- Perform rigorous, repetitive tasks, including lifting up to 35 lbs and pushing/pulling objects requiring up to 50 lbs of force.
- Stand for long durations and perform physical movements such as bending, reaching, climbing, kneeling, squatting, and stooping.
- Work around high-pressure systems and occasionally handle heavy equipment.
Qualifications:
- High school/GED with 2 years of work experience, OR
- Associate’s degree with 6 months of work experience, OR
- Bachelor’s degree.
Shift:
- Day Shift: Monday to Friday, 8:00 AM – 5:00 PM
- Occasional weekend work may be required.
- Flexibility to work various shifts, including day, swing, graveyard, weekends, holidays, and rotating schedules (e.g., 5x8, 4x10, 3x12).
