Key Responsibilities
Formulation Design & Optimization: Lead the development of robust pharmaceutical dosage forms (Oral Solids, Liquids, Topicals, or Sterile Injectables). Apply Quality by Design (QbD) principles and execute Design of Experiments (DoE) to optimize formulation parameters and process steps.
Pre-formulation & Compatibility Studies: Oversee critical physical and chemical characterizations, including API-excipient compatibility studies, solubility enhancement, and solid-state characterization.
Technology Transfer: Manage the seamless scale-up and technology transfer of developed formulations from lab-scale to pilot plant and final commercial manufacturing sites. Troubleshoot scale-up issues directly on the production floor.
Regulatory Dossier Support: Direct the compilation of technical documentation required for regulatory filings, including Product Development Reports (PDR), master formula records, and stability data protocols matching CTD/eCTD formats.
Stability Testing Supervision: Oversee formulation stability trials according to ICH guidelines to determine product shelf-life and evaluate degradation pathways under accelerated and long-term conditions.
Team & Lab Management: Lead, mentor, and evaluate a dedicated team of F&D scientists and research associates. Ensure strict laboratory safety compliance, chemical inventory tracking, and calibration of R&D equipment.
Experience
10 - 20 Years
No. of Openings
1
Education
Doctorate/PhD (Ph.D/Doctorate : Chemistry, Pharmacy)
Role
R&D Formulation Manager
Industry Type
Agro Chemical / Fertilizers / Pesticides
Gender
Male
Job Country
India
Type of Job
Full Time
Work Location Type
Work from Office
Face interview location
Impact HR and KM Solutions Near Canada Corner Signal Ravi Chambers Basements Below Laminate Gallery