Katalyst HealthCares and Life Sciences
Katalyst HealthCares and Life Sciences is hiring: Manufacturing Associate in Boe
Katalyst HealthCares and Life Sciences, Boerne, TX, United States
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.
- ssist 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.
- ssociate'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.