Technical Lead Formulation R&D

Designation : Technical Lead

Function : Formulation R&D

Functional Area : Solid Orals Formulations

Job Role Summary : Technical Lead in the Oral Solids Formulation Research & Development Department. This role encompasses new product ideation, successful product introduction, formulation & process development, technology transfer, and securing product approvals and launches.  This role emphasizes enhancing scientific capabilities and developing a pipeline of high-value products for markets in the US, Europe, Canada, Japan, and other emerging regions. It involves leading a team of research scientists dedicated to the formulation development of Oral Solid and Liquid Dosage Forms. Responsibilities include overseeing formulation design, pre-formulation studies, stability testing, scale-up, and technology transfer processes. The team will primarily focus on soft gelatin capsule technology-based products for global markets. The ideal candidate is someone currently overseeing a team of research scientists in a similar capacity.

Job Profile :

• Team Leadership:
  • Lead the assigned OSD formulation development team to create a unique and valuable product portfolio. 
• Technical Leadership: 
  • Provide technical direction to define the project scope, finalize development strategies, and manage the entire process from product introduction to launch.
  • Ensure a seamless transition from product selection to development and facilitate effective communication between cross-functional teams for successful project management.
• Product Management: 
  • Evaluate product and process complexity, innovation potential, and development challenges, defining the product strategy in line with company goals. Conduct thorough literature reviews to gather relevant scientific data. Facilitate the application process for obtaining import licenses for reference products, BE NOC's, and manufacturing site licenses.
  • Develop and optimize formulations for immediate and modified-release oral solid dosage forms. Ensure logistical readiness for smooth product execution and technology transfer.
  • Coordinate with API manufacturers, CROs, and CMOs. Work with the Global IP team to examine IP constraints, review patent summaries, and propose non-infringement strategies for formulation design. Collaborate with the Regulatory team to address submission requirements, conduct gap analyses, and ensure submission quality. Proficiently draft high-quality technical and regulatory documents. Address regulatory agency queries within deadlines to obtain timely product approvals. 

Job Requirements :

• M.Pharm with 14 - 20 years of experience in Generic Formulation Research and Development (or) Ph.D. with 10 to 16 years of experience
• Should have experience in developing simple and complex solid oral dosage forms like Osmotic Drug Delivery Systems, Extended Release & Delayed Release matrix and pellets based dosage forms, Spray Dried & Hot Melt Extrusion ASD based products, Extrusion-Spheronization based products, Tab-in-Tab press coated technology based dosage forms, Suspension / Powder layering technology based dosage forms, SMEDDS based dosage forms and Suspension / Solution filled soft gelatin capsules. 

Work / Job Experience : 14-20+ Years

Type of Experience : Generic formulations, solid, liquid orals development

Academic Qualifications :

Ph.D. / MS or M.Pharm Pharmaceutics

Job Post Link : https://tinyurl.com/5n8j74vr