Aurigene

The candidate will be responsible for preparation and submission of dossiers for NCEs and NBEs and will present it to relevant internal and external stakeholders. The candidate will represent the company with Indian regulatory agencies, including CDSCO, RCGM, Central Bureau of Narcotics and Karnataka drugs control department.

Candidate will be expected to have worked with primary cells and cell lines in immunology or immuno-oncology context. Prior experience working in development and validation of cell and gene therapy products will be preferred. M.Sc / M.Tech in Biotechnology

Should have experience in detail physical, chemical characterization. Should have experience in developing and executing bio-analytical characterization methods.

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.

Act as a Project Lead for the assigned clinical trials while supervising CRAs in their functions of monitoring and administration of clinical trials. To manage service providers, CRO and Vendors, collect quotes budget proposals, summarize and present the same to the management team.

Will be responsible for managing Discovery, Development projects end to end. Adept at managing project milestones, budget and stakeholders. Should have excellent communication skills. Must be a good negotiator and must have hands-on knowledge in MS Project, MS Excel.

Able to conceptualize and design novel vectors across expression systems including bacterial, yeast, mammalian, gene modification techniques. Experience in mass spectrometry for protein, antibody analysis.

M.Sc, M.Tech, M.Pharm with prior experience in Quality Assurance with 5-10 years in GMP pharmaceutical organization

Hands on experience in developing and manufacturing different types of enabling and novel formulations for improving the bio-pharmaceutical properties and bioavailability of New Chemical Entities