Plan and execute product development activities from concept stage to commercialization as per market and IP requirements.
Support planning, budgeting, and lifecycle management of FRD projects.
Ensure all development activities comply with cGMP and GLP guidelines.
Maintain development documentation including MFR/MFC logs, product codes, and equipment records.
Coordinate with cross-functional teams (QA, QC, RA, Production, Supply Chain) for smooth project execution.
Monitor equipment qualification activities (IQ/OQ/PQ/CQ) and maintain SOP compliance.
Manage procurement of materials required for development trials from warehouse or vendors.
Review test protocols, reports, batch records, and development documents.
Participate in investigations related to OOS, OOT, deviations, change control, and root cause analysis.
Support preparation of Product Development Reports (PDR) and regulatory documentation.
Monitor scale-up batches, process validation, and commercial validation batches.
Ensure smooth technology transfer from R&D to manufacturing.
Coordinate with vendors for outsourced testing and technical activities.
Support regulatory query responses and audits as a Subject Matter Expert (SME).
Ensure compliance with health, safety, and environmental standards.

Formulation Scientist