Join Beckman Coulter Diagnostics as a Staff Manufacturing Scientist to support the Reagent manufacturing cell culture work cell. Utilize your expertise to improve processes and ensure compliance in a fast-paced environment, driving advancements in healthcare diagnostics.
Key Responsibilities
Provide technical expertise and direction in cell culture manufacturing
Lead multi-department teams to resolve non-conforming issues
Assess and improve manufacturing processes for performance, quality, and cost
Communicate investigation status and proposals via oral and written reports
Ensure compliance with FDA Quality System Regulations, Good Manufacturing Practices, and ISO requirements
Required Qualifications
Degree in Cellular Biology, Biochemistry, Chemistry, or Biology
9+ years of experience with Bachelor's, 7+ years with Master's, or 4 years with Doctoral
Experience with aseptic techniques and/or mammalian cell culture
Understanding of in vivo and in vitro antibody/antigen production
Knowledge of analytical methods (e.g., HPLC, Octet)
Experience with stable cell generation and clonal selection
Preferred Qualifications
Project Management experience
Validation/verification experience and Process transfer
Experience in a regulated industry (e.g., FDA, ISO)
Advanced knowledge of cell culture production
Familiarity with large-scale bioreactor systems
Benefits & Perks
Paid time offMedical, dental, and vision insurance401(k)