Sun Pharmaceutical Inds Limted, R&D - Biotechnology, Baroda

Manager / Sr Manager - Biosimilar Analytical Development

Experience : 8 -15 years

Qualification : M.Sc./ Ph.D. in Immunology /Biochemistry / Life Sciences / Biotechnology 

Job Location : Baroda

Job responsibilities:

1) Work in close partnership with contract research organizations (CROs) for Bio analytical assay development.

2) Responsible for TK, PK, ADA & NAB assay development, validation at external contract organizations (CROs) in a regulated (GLP, GCLP) environment to support pre-clinical and clinical studies.

3) Responsible for assay development to detect innate immune response modulating impurities (IIRMIs) in therapeutic peptides and proteins at external contract organizations (CROs) in a regulated (GLP, GCLP) environment.

4) Responsible for assay development to detect adaptive immune response in therapeutic peptides and proteins at external contract organizations (CROs) in a regulated (GLP, GCLP) environment.

5)  Serve as the bioanalytical representative at project team meetings and provide scientific and operational oversight of bioanalytical activities conducted at CROs including reagent generation, assay development and validation.

6) Work independently and in collaboration with a subject matter expert (SME) representative of the clinical & non-clinical group.

7)  Identification & screening of CROs for Bioanalytical services.

8) Provide guidance to contract organizations (CROs) on assay development, experimental design, troubleshooting and sample analysis.

9) Review of method development reports (MDRs), validation reports and bio analytical test procedures (ATPs).

Send in your resume to Rosemary.varghese@sunpharma.com