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