The incumbent will be responsible to support analytical research and development activities for NCE (new chemical entity), LCM (life cycle management) and NEB (new established brand) projects. 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 various documentations such as specifications, test procedures, method validation plans, protocols, reports, stability data, SOPs, CMC technical sections for regulatory submission etc.
Post: Principal Scientist Analytical Research and Development (ARD)