Manufacturing Associate
: Job Details :

Responsibilities:

• Support daily manufacturing activities for clinical and commercial manufacturing programs.
• Execute and document batch records following Good Documentation Practices (GDP).
• Review and revise SOPs, batch records, and manufacturing documentation.
• Perform microbial fermentation and mammalian cell culture, including bacterial fermentation and single-use mammalian systems (up to 1000L).
• Operate upstream and downstream processing equipment, including continuous flow centrifuges, depth filtration, chromatography (AKTA), and HPLC systems.
• Ensure compliance with GMP, QA/QC policies, and regulatory requirements.
• Support deviation and CAPA resolution in collaboration with quality teams.
• Assist in MSAT/PD during development and scale-up activities.
• Maintain and ensure proper calibration and preventative maintenance of equipment.
• Enforce safety policies and ensure compliance within the team.

Requirements:

• Associate's, BS, or MS degree in a Scientific or Engineering discipline.
• 4+ years (AS/BS) or 3+ years (MS) of experience in biomanufacturing.
• Experience in microbial systems and cGMP environments is essential.
• Strong understanding of Quality Management Systems and GMP principles.
• Familiarity with upstream and downstream processing in a biomanufacturing setting.