Senior Manufacturing Scientist
Listed on 2026-06-06
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Manufacturing / Production
Senior Manufacturing Scientist – Beckman Coulter Diagnostics
Position located in Chaska, MN. Full‑time on‑site in Reagent Operations reporting to the Manager of Manufacturing Science. Responsibilities include supporting the daily production of reagent manufacturing cell culture work cell, leading cross‑functional teams, improving manufacturing processes, and ensuring compliance with FDA, GMP and ISO regulations.
Responsibilities- Provide technical expertise and direction in cell culture manufacturing, addressing issues as they arise.
- Lead multi‑department teams to resolve non‑conforming issues for products, processes, and manufacturability.
- Assess and improve manufacturing processes and systems for performance, quality and cost.
- Communicate investigation status and proposals via oral and written reports; update documentation promptly.
- Ensure compliance with FDA Quality System Regulations, Good Manufacturing Practices, and ISO requirements.
- Degree in Cellular Biology, Biochemistry, Chemistry or Biology (Bachelor’s ≥5 years, Master’s ≥3 years, Doctoral ≥1 year) with experience in aseptic techniques and/or mammalian cell culture.
- Understanding of in‑vivo and in‑vitro antibody/antigen production.
- Analytical methods experience (e.g., HPLC, Octet).
- Experience with stable cell generation and clonal selection.
- Project management experience.
- Validation/verification experience and process transfer.
- Experience in a regulated industry (e.g., FDA, ISO) with advanced knowledge of cell culture production.
- Familiarity with large‑scale bioreactor systems.
Salary range: $95 K–$115 K (subject to change). Eligible for bonus/incentive pay. Benefits include paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
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