Sr. Research Scientist or Team Leader -Complex Injectable, F&D

Alembic Pharmaceuticals Limited is looking Sr. Research Scientist or Team Leader for Complex Injectable (Formulation & Development) based at our Injectable R&D Vadodara.

Role & Responsibilities :

• Demonstrate expertise in drug device combination product (pen injector/auto injector/PFS) development device suitability, functionality testing as per ISO standards and comparative threshold analyses etc.
• Hands on experience in Peptide based injectable product development & peptide characterization to prove the sameness. Good understanding of Immunogenicity concept & bioassay for peptide.
• Proficient in technology transfer of device based products, Suspension products , terminally sterilized and lyophilized products bottleneck/gap identification & trouble shooting
• Good understanding of intellectual property with focus towards developing a non-infringing strategy for patent claims and develop a Para IV strategy for first to file products
• Able to evaluate and design the strategy for 505 (b) (2) products proof of concept studies and regulatory requirements
• Having sound understanding for regulatory query response
• Have good experience in - briefing book preparation, biowaiver control correspondence and Pre-ANDA meeting
• Understanding of QbD applicability and Statistical tool in Product development to ensure built in quality
• Hands on expertise in Designing & monitoring product development strategies - Literature, Patent landscape, Sourcing, Pre-formulation, Prototype development, Formulation & Process Optimization etc.

Interested Candidates may share their CV to msnt@alembic.co.in with position title : "SRS or Team Leader-Injectable".