Aurigene is a clinical stage biotech company engaged in discovery and clinical development of novel and best-in-class therapies to treat cancer, and a wholly owned subsidiary of Dr Reddy's Laboratories Ltd. Aurigene is focused on precision - oncology and has multiple compounds at different stages of pre-clinical development and several projects in global clinical development.
Post : Research Associate, Sr. Executive / Assistant Manager
Research Associate - Pharmaceutical Development
Candidate Profile : M.Pharm (Pharmaceutics) with 1-3 years' of relevant experience in formulation development.
Location : Bangalore.
Roles and Responsibilities :
• Preclinical formulation development of NCE's for animal studies.
• Hands on experience in physicochemical characterization, solid state characterization, polymorph screening and salt screening techniques.
• Hands on experience in using and interpreting data from techniques like DSC,PXRD,TGA,DVS, Hot Stage Microscopy, FTIR, NMR, HPLC, LCMS etc.
• Execute literature search, pre- formulation studies, lab scale development and conduct stability as per ICH guidelines.
• Plan and execute solid state screening, polymorph screening ,salt screening, pre¬formulation studies independently with minimal supervision.
• Development of different types of enabling and novel formulations for improving the bio- pharmaceutical properties and bioavailability of New Chemical Entities (NCE's).
• Contribute scientifically to overall pharmaceutical development processes during NCE development.
• Preparation of protocols guidelines, SOPs for lab equipment/ instruments and processes.
• Should have good understanding about principals of GLP,GMP and ICH guidelines.
• Should understand systems and process pertaining to safety, health and environment.
Sr. Executive/ Assistant Manager - Cell & Gene Therapy - QA
Candidate Profile : Masters / M.Tech/ M.Pharm (Biotechnology / Molecular Biology / Biochemistry with prior experience in Quality Assurance) with 8-10 years in Biopharmaceutical Industry (preferably in Cell & Gene therapy products / CAR-T).
Location : Bangalore.
Roles and Responsibilities :
• Responsible for review of analytical documents from early stage to late-stage development, technology transfers to GMP production of Biologics/Cell & Gene therapy products/ CAR-T.
• Review analytical documentation such as protocols, SOPs, test methods, batch release COAs through collaboration with QC scientists, to achieve the highest quality from technical and compliance perspectives.
• Review development documents for regulatory submissions, including analytical method development/validation reports.
• Responsible for investigations against laboratory Incidents, OOS, OOT encountered with aim of root cause identification and CAPAs.
• Review data for specifications proposals and test methods for raw materials, intermediates, cleaning, CAR T and lentiviral vectors.
• Responsible for maintaining and tracking internal departmental documents and reports.
• Maintain and update internal departmental procedure in accordance with ICH and global regulatory guidelines.
• Ensuring compliance of quality systems by continuous monitoring of Quality controls unit.
Interested candidates may send their resume to : gayathiri_n@aurigene.com
Last Date : 25th January 2025
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