Intas Pharmaceuticals Ltd Job Vacancy for Ph D In Molecular Biology/ Virology/ Microbiology/ Cell Biology
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| Intas Pharmaceuticals Ltd Job Vacancy for Ph D In Molecular Biology/ Virology/ Microbiology/ Cell Biology |
Position: Head, Analytical Development, Cell and Gene Therapy
Job Summary:
She/He leads all assays/tests-related to cell-based products, viral vectors (AAV, LV) and plasmids, required to support the development, qualification, validation, and transfer of all required assays and is responsible for the review and approval of related reports and serves as the Subject Matter Expert (SME) for both internal and external assay development/analytical development projects for cell and gene therapy products and would also include testing of plasmids and other critical raw materials for all gene therapy programs.
The role directs the efforts of a team of scientists in the development of analytical methods to determine the purity, potency, strength and identity of drug substance, drug product and process intermediates.
The scope of this position currently focuses on R&D and early clinical development, but later it will extend to commercialization and life cycle management.
Roles and responsibilities:
- Leads, and actively contributes to, the development of science-driven, phase appropriate, and risk-based analytical development strategies to support development projects from candidate nomination to clinical development and commercial manufacture.
- Drives assay development to support timely IND, BLA, and all relevant regulatory filings within India and outside.
- Manages and mentors’ scientists of varying levels to build a highly functional Analytical Development (AD) team that is cross-trained in at least two AD assay areas.
- Communicates and consults with key personnel in QC, executive management, Pharm/Tox, Research, Regulatory and Clinical. Keeps peers and management informed about analytical issues and their impact on project timelines.
- Manages Analytical Development (AD) group efforts, including assay development, method qualification and transfer to QC, and assay support of Process Development and other groups as needed.
- Provides scientific and operational advice to AD personnel to facilitate their assay development activities and will be primary contact for representing AD to other departments.
Ensure a continued information flow among other departments and external collaborators/partners
- Represents Intas AD group at regulatory authority meetings and teleconferences for analytical questions and maintains awareness of new technology.
- Presents at external meetings or publishes in peer-reviewed journals
- Assures the effective transfer of all methods to Quality Control in a phase-appropriate fashion, to support clinical, and commercial activities.
Desired Exp. and Qualification:
A PhD (10-14 years) in molecular biology / virology / Microbiology / cell biology with min 8 years of experience in biologics and/or gene therapy analytical development roles in a pharma, biotech or related environment.
Interested candidates can share their CVs on
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