Manufacturing Technician

Title: Manufacturing Tech
Location: Pearl River, NY OR Ridgefield, NJ
Pay: $20-30/hr - Based on shift and experience
Contract: 12+ months 

We are seeking a highly motivated and detail-oriented Cell Culture Manufacturing Technician to join our cGMP commercial manufacturing facility. In this role, you will be responsible for the execution of standard operating procedures (SOPs) and batch records in the production of Drug Substance within the dedicated Cell Culture area, focusing on cell maintenance and virus stock generation.

Responsibilities

• Execute aseptic cell culture techniques, including sampling, analysis, cell splitting, and virus stock preparation in flasks and bioreactors.
• Perform cell scale-up to bioreactors for protein production.
• Set up, operate, and maintain 100L single-use bioreactors (SUBs).
• Perform cleaning and preparation of workspaces and biosafety cabinets.
• Conduct preventive maintenance and changeovers for area equipment, including biosafety cabinets, shaker incubators, tabletop centrifuges, and SUBs.
• Perform aseptic sampling and environmental monitoring.
• Analyze cell culture samples using cell counters and microscopes for contamination checks.
• Maintain accurate and compliant documentation (GDP).
• Participate in cGMP training and adhere to all safety protocols.
• Assist in troubleshooting manufacturing issues and participate in investigations.
• Contribute to the cleaning and maintenance of the cGMP facility.
• Adhere to material, personnel, and equipment flow SOPs.
• Work a flexible schedule, including weekends and holidays as needed.
• Assist with deviation and CAPA management.
• Potentially cross-train and operate in flex areas.

Required Qualifications

• High school diploma or equivalent
• 1-2+ years of work experience or training in a cGMP manufacturing environment.
• Proficiency in aseptic technique.
• Ability to operate and maintain laboratory equipment, including biosafety cabinets, incubators, centrifuges, and bioreactors.
• Ability to follow SOPs and batch records.
• Excellent documentation skills.
• Strong communication and interpersonal skills.
• Ability to analyze manufacturing data.

Preferred Qualifications

• Experience with cell culture maintenance and scale-up.
• Experience with 100L single-use bioreactors (SUBs).
• Knowledge of the Baculovirus Expression Vector System (BEVS) manufacturing process.
• Experience with cell analysis and data interpretation.
• Experience with environmental monitoring.
• Experience with preventative maintenance of equipment.
• Experience with deviation and CAPA management.