Scientist - I (Process Expert) – Late Stage CMC
Job Description:
Job Title: Scientist - I (Process Expert) – Late-Stage CMC
Reporting to: Associate Director - Late-Stage CMC
Location: Hyderabad
Qualification: M. Pharm (Pharmaceutics / Pharmaceutical Technology / Pharmaceutical Sciences)
Experience:
At least 10 years of industrial experience technical scale up & technology transfer.
Hands-on experience with oral and sterile formulations
Experienced in working with external manufacturing sites (CMOs)
Key Accountabilities and Responsibilities:
Carry out: QbD process risk assessment & mitigation plan with First Time Right (FTR) approach from technical scale up through commercial supply to achieve Derive a robust & reproducible manufacturing process while interfacing with CMC team, QA, RA
Carry out: Execution of technical scale up and registration batches, define desig...