5+

Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background, with proven competency in patient safety pharmacovigilance/clinical development.

PhD, MS, BS in relevant functions in the Pharmaceutical, Biotechnology Industry, or equivalent. Subject matter expertise in regulatory affairs and related activities.

Familiarity with high-performance organizational tools and a strong understanding of digital manufacturing processes, computer system validation requirements, and quality management within biologics production and quality.

Glenmark Pharmaceuticals Limited is a research‐led, global pharmaceutical company, having a presence across branded, generics, and OTC segments; with a focus in the therapy areas of Respiratory, Dermatology and Oncology.

Experience in production planning, change control, line clearance, deviation handling, autoclave operation TS and component, aseptic & controlarea operation, documentation, both SVP and LVP manufacturing etc.

Develop, optimize, and publish high-quality analytical methods using high-field NMR and qNMR applications; publications may include white papers, application notes, or journal articles ; Acquire high resolution qNMR spectra and implement structural elucidation for obtaining chemical structural information to develop QM spectral analysis models

Work closely with cross-functional teams including preclinical, clinical, and regulatory teams to guide decision- making and project direction. Utilize software tools such as WinNonlin, R, SAS, Matlab, Monolix, GastroPlus Simcyp, PK-Sim, and other similar platforms for M&S.

Having Injectable Experience of Shop floor ac-tivities like vial washing, compounding, filtration, filling and Sealing, Autoclave, Garment Washing machine, Lyophilizes

Must be from Formulation Industry. Undertake method development, troubleshooting and method validation to GMP and ICH. Investigation of non- conforming samples, CAPAs, data evaluation and reporting.