Manufacturing Associate

This is a Night Shift position:

This role requires strong adherence to aseptic techniques, working in controlled environments, and maintaining compliance with cGMP standards.

Key Responsibilities:

• Execute core manufacturing tasks, including:
• Weighing and preparing materials.
• Operating filtration systems and managing fermentation processes.
• Performing inoculation of cells and harvest operations.
• Utilizing chromatography and tangential flow filtration (TFF) equipment.
• Conduct in-process testing such as pH, conductivity, spectrophotometry, osmolality, and cell counts.
• Prepare media and buffer solutions according to production needs.
• Ensure accurate documentation of all activities in batch records and logs.
• Maintain cleanroom environments and dispose of materials in compliance with protocols.
• Report any deviations or unexpected issues promptly to supervisors.
• Support process development teams with technology transfer to manufacturing.
• Adhere strictly to safety and operational procedures.

Qualifications:

• Education: An associate degree or higher in Biology, Chemistry, Biotechnology, or a related field is preferred. Equivalent hands-on industry experience (1-4 years in biologics manufacturing) is also welcomed.
• Skills & Knowledge:
• Familiarity with GMP protocols and biotechnology operations such as aseptic filtration, fermentation, chromatography, and TFF processes.
• Basic troubleshooting skills for equipment and processes.
• Strong ability to follow detailed instructions and work both independently and collaboratively.
• Proficiency with basic software tools, including word processing and data management systems.
• Additional Requirements: Flexibility to work night shifts and meet deadlines under a fast-paced manufacturing environment.