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.
