Consultant at Randstad
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Deputy General Manager/General Manager/Head - Analytical Chemistry - R&D - PhD (15-18 yrs)
Position: Deputy General Manager / General Manager Analytical Research API
Department: Pharmaceuticals Science and Technology, Analytical Development and Research
Reporting to: Head R&D
Experience: 15-18 years . At least 5 years as Head of Analytical Research of API
Qualifications: PhD in Analytical Chemistry
- Managing Lab functions related to Analytical Research and development; during various stages of Drug substance process development and manufacturing of Drug substance for Clinical trial supply.
- Responsible for analytical method development, stability studies, method validation, documentation and coordination (On site and Global);
- Responsible for preparation and review of scientific report writing justifications, justification for mutagenic impurities (MI- s), implementation of QbD for method development, compliance & documentation as per regulations.
- Responsible for preparation and 1st QC review of IND, CTA, IMPD document and NDA document section related to analytical research. Also responsible to prepare the response for regulatory queries related to IND, CTA and IMPD fillings.
- Trained the researcher on advanced Analytical Techniques and their Applications, Analytical method validation, Analytical Method Development and Pharmaceutical Development Process.
- Responsible for continuous functional improvement of Analytical Research Division
- Responsible to support API solution project for structural characterization and physical characterization.
- Responsible for preparation of justification for purchase and installation of Capex items related to Analytical Research division.
- Responsible for preparation and review of the departmental standard operating procedures.
- Responsible for preparation and review of specification of Raw materials, key starting materials, inprocess, intermediates, drug substance.