Job Description
Role & Responsibilities
Lead formulation development projects for OSD, liquid, nasal, ophthalmic, and injectable dosage forms.
Apply IR (Immediate Release) and MR (Modified Release) formulation strategies to meet therapeutic and regulatory requirements.
Design and execute optimization trials, scale-up activities, and exhibit batches in compliance with global regulatory standards.
Manage technology transfer from R&D to manufacturing sites, ensuring robust processes and smooth handover.
Address and resolve regulatory queries related to formulation, process development, and exhibit batches
Collaborate with cross-functional teams (Analytical, Regulatory Affairs, Manufacturing, QA/QC) to ensure project success.
Provide technical leadership, mentoring, and guidance to junior scientists and team members.
Ensure compliance with cGMP, ICH, FDA, EMA, and other regulatory guidelines throughout development and scale-up.
Prepare and review technical documents including development reports, batch records, and regulatory submissions.
Drive innovation in formulation approaches to improve product quality, stability, patient compliance, and cost-effectiveness.
