Manufacturing Associate - Katalyst Healthcares & Life Sciences : Job Details

Manufacturing Associate

Katalyst Healthcares & Life Sciences

Job Location : Boerne,TX, USA

Posted on : 2025-01-01T06:37:59Z

Job Description :

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.

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