2-3

Execute, monitor, report and interpret preclinical, clinical and BABE studies at CROs to support various regulatory submissions within targeted timelines, budgets, quality and regulatory guidelines; identify health hazard and assess risks associated with pharmaceuticals, chemicals, intermediates, impurities, etc. by toxicological review and derivation

Presentation and communication of data to stakeholders, work in collaboration with the teams within and across the department. Ph.D in Life Sciences, Pharmacology, Biotechnology, Biological Engineering.

Perform and review method validation of Assay, Dissolution, Related compound and Residual solvents etc. Preparation of method validation/verification protocol.

Biocon Biologics is driven by a strong sense of purpose and the unwavering commitment to serve patients and healthcare systems across the globe by unlocking equitable access to high quality biosimilars.

Patent search, literature search, Pre formulation study, Formulation optimization with QBD approach. Scale up at plant level.

Experience into Complex Injectable and Complex Equipment like HPH, Isolator, Wet Mill, ANFD. Experience in injectable and Ophthalmic dosage form like suspension & Gel forming and simple ophthalmic range.

Accuprec Research Labs Pvt Ltd. is FDCA approved, OECD-GLP, NABL accredited and ISO 9001:2015 certified CRO. Head Quarter of the CRO is located at Ahmedabad and branch offices at Canada and USA.

Strong knowledge of GMP, GDP, and regulatory compliance for pharmaceutical warehousing. Exposure of various instruments/ software like empower 3, LIMS and other software.

Exposure to OSD Manufacturing operations like Granulation, Compression, Pellet coaling, Capsule filling, Primary Packing & Secondary Packing. Expertise in e-BPR and e-log will he added advantage. Experience of HPLC, UV spectrophotometer and Dissolution Tester operation. Experience of Analytical Method Validation/Transfer. Experience of GC, ICPMS and/or LCMS operation.