Department:- Formulation Development Injectable Tech Transfer

Designation:- Manager

Total experience: - 12+ years

Total Openings:- 01

Key Responsibilities

- Lead end-to-end technology transfer activities for sterile injectable products, including liquid vials, lyophilized products, prefilled syringes, and ampoules.
- Review and assess technology transfer documents, including manufacturing processes, batch records, product specifications, and analytical methods.
- Coordinate with R&D;, Manufacturing, Quality Assurance, Quality Control, Engineering, Validation, Regulatory Affairs, Supply Chain, and Project Management teams.
- Prepare and review technology transfer protocols, reports, risk assessments, and gap analyses.
- Support process scale-up, engineering batches, exhibit batches, process performance qualification (PPQ), and commercial validation activities.
- Ensure compliance with cGMP, data integrity requirements, and global regulatory expectations including US FDA, EMA, MHRA, WHO, PIC/S, and other applicable agencies.

📌 Manager Formulation Development Injectable Tech Transfer (Halol)
🏢 BDR Pharmaceuticals
📍 Halol