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 recent 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 [email protected]

📌 Assistant General Manager (Maharashtra)
🏢 Harman Finochem
📍 Maharashtra