Manufacturing Associate

Manufacturing Associate – a contract position in Pearl River, NY, focused on cGMP production of Flublok Drug Substance using insect cell culture and bioreactor scale‑ups.

Title:

Manufacturing Associate

Location:

Pearl River, NY
Type:
Contract
Pay: $21.56–$26.56 per hour

• Execute standard operating procedures (SOPs) and batch records for production of Flublok Drug Substance within the dedicated Cell Culture area.
• Perform aseptic cell culture sampling and analysis, cell splitting for cell stock maintenance in flasks, preparation of virus stock in flasks and bioreactors, and scale‑up of cell culture to bioreactors for protein production.
• Set up and operate a 100 L single‑use bioreactor (SUB) and perform cleaning and maintenance of process equipment.
• Maintain aseptic technique and perform preventive maintenance and changeovers for area equipment such as biosafety cabinets, shaker incubators, tabletop centrifuges, and the 100 L SUB.
• Carry out aseptic sampling when required using environmental monitoring equipment.
• Aid in troubleshooting problems in the cell culture area.
• Cross‑train and operate in flex areas as business needs dictate.
• Perform cell analysis and data interpretation using the cell counter and microscope for contamination checks.
• Assist in resolving manufacturing quality issues and interacting with departmental personnel.
• Manage and analyze manufacturing data in accordance with good documentation practices (GDP).
• Participate in cleaning of the cGMP facility and follow established SOPs for material and equipment flow.
• Work a flexible schedule, including weekends and holidays, and respond to compliance notifications of deviations and CAPAs.
• Other duties as required.

• High school diploma with at least 2 years of experience, or training within a cGMP manufacturing environment.
• General knowledge of cGMP, GDP, and SOPs.
• Good communication and social skills.
• Basic understanding of the Baculovirus Expression Vector System (BEVS) manufacturing process is desired but not required.