Executive MS&T; / Technology Transfer to support the successful transfer of recent products from R&D; to the manufacturing site. The role involves coordination of scale-up and exhibit batches, documentation preparation, technical support during execution, and collaboration with various departments to ensure timely and smooth product introduction and regulatory compliance.
Key Responsibilities:
Coordinate the transfer of products from R&D; to the manufacturing site.
Review and finalize technology transfer documents from R&D; and external partners.
Liaise with site teams to ensure readiness and approval of all TT documents.
Identify and address technical gaps for smooth current product introduction.
Prepare and review batch records, protocols, and reports for scale-up batches.
Monitor and provide technical support during execution of scale-up and exhibit batches.
Support the regulatory team by providing required documentation for product filings.
Ensure availability of all required materials (API, raw materials, packaging, consumables).
Oversee sampling and stability testing as per approved protocols.
Prepare and review SOPs; ensure compliance with cGMP guidelines.
Assist production and quality teams during batch execution activities.
Support Quality Management System (QMS) activities including deviations, CAPAs, and change controls.
Qualification, Experience and Skills required:
B.Pharm / M.Pharm / M.Sc. with 2–5 years in pharmaceutical manufacturing, Technology Transfer or MS&T;
Experience in batch record preparation, production compounding, and IPQA batch monitoring.
Familiarity with R&D; development activities.
Robust cross-functional coordination and communication skills.