Scientist Jr. or Sr. - Purification

Location
94043, Mountain View
Posted
Nov 07, 2018
Required Education
Masters Degree/MBA
Position Type
Full time

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.

 Quality/Regulatory:

• 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.