We are actively seeking a Research Scientist to join our growing team. This position will be responsible for formulation product development and submission of regulatory documents for both oral solid dose (OSD) and sterile injectable products.
- Technology transfer from scale-up until commercialization of products; technical support during execution of scale-up, pre-exhibit batches, and exhibit batches.
- Assist in the successful completion of new launches, batch size increases, and other validation projects as per commercial requirements.
- Prepare and review TTD documents (PDP, MFC, PDR); review commercial BPRs, validation protocols, and reports for the plant.
- Plan scale-up and exhibit batches in coordination with departments such as R&D, Project Management, and PPIC through weekly meetings.
- Collaborate with QA, QC, and Production on required activities, such as: documentation of scale-up and exhibit batches, TT/ RA, change controls, customer complaints, and troubleshooting, as needed.
- Coordinate with R&D and other related departments on MFC, MPC, BOM, Procurement, etc., as well as with external vendors.
- Provide support for the design of punches and machinery to produce quality products; this may include technical support and recommendations for process development and new product development projects.
- Bachelor's degree in relevant scientific discipline required.
- Master's / Ph.D preferred.
- Equivalent experience will be considered.
- Minimum of six (6) years of related experience in the pharmaceutical industry