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 new 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.
- Strong cross-functional coordination and communication skills.