Vacancy in Intas Pharmaceuticals Ltd Ahmedabad.
Vacancy in Intas Pharmaceuticals Ltd
Deatils:
We at Intas Pharmaceuticals Ltd, Ahmedabad are hiring.
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.
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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.
Responsibility:
- Communicates and consults with key personnel inQC, executive management, Pharm/Tox, Research,Regulatory and Clinical.
- Keeps peers andmanagement informed about analytical issues andtheir 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 personnel to facilitate their assay developmentactivities and will be primary contact for representing to other departments.
- Ensure a continued information flow among otherdepartments and external collaborators/partners.
- Represents Intas AD group at regulatory authoritymeetings and teleconferences for analytical questionsand maintains awareness of new technology.
- Presents at external meetings or publishes inpeer-reviewed journals- Assures the effective transfer of all methods to Quality Control in a phase-appropriate fashion, tosupport clinical, and commercial activities.
Desired Exp. and Qualification:
A PhD (10-14 years) in molecular biology / virology/Microbiology/cell biology with min 8 years ofexperience in biologics and/or gene therapy analyticaldevelopment roles in a pharma, biotech or related environment.
Interested candidates can share their CVs on Below Button.
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