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

Alembic Pharmaceuticals

5 - 10 years

0 Lacs

Vadodara

Posted:1 day ago| Platform:

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Skills Required

Formulation Development Characterization Peptides Complex Injectables Injectables Technology Transfer

Work Mode

Work from Office

Job Type

Full Time

Job Description

Alembic Pharmaceuticals Limited is looking Sr. Research Scientist or Team Leader for Complex Injectable (Formulation & Development)

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".

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