MSAT Experienced Scientist
On-siteWilson, North Carolina, United States
Job Summary
Support MSAT laboratory start-up activities by preparing SOPs, coordinating instrument installation, and executing reduced-scale CHO cell culture model studies. Lead development and qualification of cell culture protocols, generate reports, and conduct scientific reviews to support commercial scale cGMP manufacturing. Collaborate with manufacturing operations to assist process validation, provide technical support for investigations, and ensure right-first-time process execution through batch record automation. Lead training on new processes and equipment while fostering a culture of lean principles and continuous improvement.
Required Qualifications
- A minimum Bachelors Degree in Biology, Pharmacy, Chemical Engineering, Bioprocess Engineering, or similar field
- B.S. with a minimum 4 years of relevant experience or M.S. with a minimum of 2 years relevant experience
- Proven expertise in CHO cell culture (upstream) biological process development, with the ability to plan and execute experiments or projects independently with minimum supervision
- Strong hands-on laboratory mindset and expertise in laboratory scale bioreactor operation including set up and tear down of bioreactors, conduct sampling and testing
- Experience within a regulated biologics or pharmaceutical industry
- Solid understanding of process control strategy and its implementation in the manufacturing environment
- Excellent oral and written communication skills
- Strong technical writing capability with keen attention to detail
- Self-motivated with a dedication to staying up to date with regulatory and technical developments in the industry
- Ability to work independently as well as in a cross-functional team environment, demonstrating strong collaboration skills and flexibility
- Proven track record to adapt to rapid changes in project priorities and requirements
- Advanced root cause problem solving with strong scientific data driven decision making ability
- 5 days onsite location is required
- Availability to work occasional weekend shifts
Desired Qualifications
- A minimum 2 years of experience within a regulated biologics or pharmaceutical industry
- Experience in scaling up a cell culture process from a bench-top bioreactor to a production scale
- Experience in the commercial biotherapeutics drug substance manufacturing process tech transfer
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