Aurigene

Define and execute the discovery biology strategy across modalities small molecules, antibody, ADC, and cell & gene therapy in alignment with company goals.

Experience in the development and application of pharmacometric models to support drug development and regulatory submissions.

Experience in preparation of ultra competent cells and transformation with chemical and electroporation methods.

Lead the entire recruitment lifecycle including manpower forecasting, budgeting, sourcing, interviewing, selection, onboarding, induction, and background verification.

M.Sc. Organic Chemistry with 10-14 yrs total experience, 2-3 yrs. experience as Process Chemist and 6-7 yrs experience in API QA

Expert in designing and executing DMPK studies to support antibody-drug conjugate and monoclonal antibody programs, from discovery through IND-enabling stages.

Must have hands on experience in linker- payload synthesis and overall understanding of ADC. Should be able to design and execute synthesis of complex drug linkers and ADC payloads.

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