5+

M.Sc. (Biotechnology/Microbiology), M.Pharm./B.Pharm./B.Tech/B.Sc. (Chemistry) ; 2 to 10 years of relevant experience in Biologies / Biopharmaceuticals.

Having knowledge of Analytical Method Validation, Verification & Method Transfer, Handling skill for data interpretation, troubleshooting, Pharma knowledge of Solid as well as Quality processes, USFDA, MHRA, ANVISA & other regulatory exposures is preferred, including ICH guidelines.

Coordinate with Engineering, QC, Production and other departments. Ensure compliance with GMP standards, SOPs and applicable regulatory guidelines.

Familiarity with CSV, categorization, risk assessment and instrumentation qualification. Candidates with an OSD/Injectable/API background can be considered.

Operating equipment such as reactors, Sparkler Filters, Candle Filters, centrifuges and dryers as per SOP. Knowledge of GMP, cGMP and Data Integrity.

Lead pipeline strategy and introduce new products to the in-house pipeline through ROI and feasibility checks. Scout unmet needs, new therapies, dosage forms and spaces to enter, with break-even estimations 

Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems

Aseptic Filling / Filtration Operator / Vial Washing / Autoclave / Microsphere Manufacturing / Controlled Area.

Alembic Pharmaceuticals is seeking Medicinal Chemistry Lead to spearhead our small-molecule and peptide drug discovery programs.