Principal Scientist - Analytical Research and Development (ARD) (JR28022017) Navi Mumbai, India
This position is for a group leader’s role in the analytical line for the pharmaceutical sciences organization. The incumbent will be responsible to supervise and assist team members who in turn are supporting analytical research and development activities (methods development, validations, transfers, documentation, stability, etc.) for API and formulation projects within the sphere of NCEs, LCM and generics. The person hired into this position will work in close collaboration with other functional line colleagues (chemistry, formulation, API scale up etc) to best support product and process development in line with project plan. Candidate will be responsible for supporting multiple projects and the interfacing with various customers and partner groups across the organization such as global development team, regulatory, quality, manufacturing and clinical organizations as well as coordinate the analytical activities outsourced to vendors. The candidate will be responsible for authoring/reviewing various documentations such as specifications, test procedures, method validation plans, protocols, reports, stability data, SOPs, CMC technical sections for regulatory submission etc. The candidate will also be expected to lead multi-functional Pharm Sci Teams in a matrix environment for developmental activities from the early development stage to registration and commercialization. Projection and effective management of resources to ensure timelines, budgets and deliverables are met as per project requirements will also be a part of the role.
PhD / M Pharm / MSc in Analytical / Pharmaceutical Chemistry / Instrumentation with 10 - 15 years of experience in Industry