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 design space and control strategy to achieve new product submission and commercial launch with adherence to timelines while interfacing with multidiscipline team including CMC, quality and regulatory team.
Support: New product launch activities and commercial manufacturing as per business requirement to achieve Continues product supply while interfacing with multidiscipline team including CMC, quality and regulatory team.
Support & Ensure: Identification of CDMO & CMOs meeting global regulatory standards and develop request for proposals to achieve reliable partners to support drug product registration and commercial supply while interfacing with multidiscipline team including CMC, quality and regulatory team.
Support & Ensure: Driving late-stage CMC deliverables in collaboration with internal and external stake holders to achieve Timely completion of projects in line with the requirements while interfacing with CRO/CMO and Project Management
Carry out: Troubleshooting and root cause analysis using best in class scientific approaches to address challenges faced during product life cycle to achieve Continues product supply while interfacing with CMC, QA, RA, CMO/CDMO
Carry out: Prepare and review protocols, reports, validation plans and other technical documents like batch record, stability protocol & report to achieve Compliance to quality systems while interfacing with CMC team, QA, and RA
Carry out /Support: Represent and collaborate with relevant global forums/stake holders to inculcate best practices in industry related to pharmaceutical technology to create a competitive advantage to achieve Capability building while interfacing with Internal a& external stake holders.
Performance Indicators:
Projects milestones – timely completion
Technology – Contribute to technology development, through external partners.