Scientist Jr. or Sr. - Purification
Recovery and Purification Process Optimization:
• Provide hands-on capabilities and technical expertise at bench-scale with a focus on the development of optimized recovery/purification processes for bacterially expressed proteins with an emphasis on developing robust purification technology platforms. Experience with DOE concepts and tools desirable.
• Application of in-process tools/analytical methods. Identify and implement in-process analytical tools and techniques and support refinement of analytical techniques to ensure the continuing success of active product development programs from research through clinical trials/product commercialization.
Process Scale Up:
• Provide technical expertise and support GMP scaleup efforts (multi-kg scale) aimed at the generation of optimized protein recovery processes from bacterial expression platforms that lead to sustained manufacturing consistency, robustness, scalability, increased efficiency, and reduced costs.
• Partner with Quality function to provide oversight of external GMP manufacturing activities in cooperation with contract manufacturers/ labs/partnering entities, as required.
• Provide required support to the Quality/Regulatory functions to establish, implement, maintain, and appropriately document product related process development, tech transfer, and GMP manufacturing activities.
• Prepare technical reports in support of planned regulatory submissions and future process development work.
• Support successful preparation of CMC sections of regulatory submissions, as required.