Source description
About the role
M/s. Harman Finochem ltd is hiring for "AGM R&D Formulation (OSD Oncology)" at Koperkhairne, Navi Mumbai location: Position Summary : Set up, commission, and lead a new state-of-the-art oncology OSD formulation R&D lab. Drive the initial infrastructure setup, equipment procurement, and team hiring. Establish product development pipelines for oncology Oral Solid Dosage (OSD) products. Key Responsibilities : Lab Setup & Commissioning : Infrastructure Design: Collaborate with projects and engineering teams to design containment areas. Equipment Procurement: Identify, select, and procure R&D lab and pilot-scale machinery. Containment Systems: Oversee installation of isolators, mist showers, and HVAC for HPAPIs. Vendor Management: Negotiate contracts with analytical instrument and processing equipment vendors. Systems, QMS & Compliance Establishment: SOP Authoring: Write and implement standard operating procedures (SOPs) for the new lab. QMS Implementation: Establish Quality by Design (QbD) frameworks and risk management protocols. Safety Protocols: Design safety guidelines for handling OEB 4 / OEB 5 oncology compounds. Data Integrity: Implement software and documentation systems complying with 21 CFR Part 11. Product Development & Pipeline Planning: Portfolio Strategy: Plan the initial product pipeline based on market feasibility. Formulation Strategy: Direct the development of immediate and modified-release oncology OSD products. Tech Transfer: Design the technology transfer framework from the new lab to manufacturing units. Team Building & Leadership Preferred candidate profile : M.Pharm / Ph.D. (Pharmaceutics preferred). 12-14 years of experience in Pharmaceutical Formulation R&D. Hands-on experience in Oral Solid Dosage (OSD) Oncology Products. Experience in development for regulated markets such as USFDA, EMA, MHRA, Health Canada, and other global markets . Interested candidates can share their CVs at poonamm@harmanfinochem.com