Manager / Sr Manager - Biosimilar Analytical Development in Sun Pharmaceutical Inds. Limited

Job Posted on Feb 16, 2023

Recruiter Type:	Company
Company Name:	Sun Pharmaceutical Inds. Limited
Address:	R&D - Biotechnology, Baroda
Contact Person:	HR
Email Address:	rosemary.varghese@sunpharma.com
Required in:	R&D
Job Department(s):	Research
Job Title:	Manager / Sr Manager - Biosimilar Analytical Development
Qualification:	M.Sc./ Ph.D. in Immunology /Biochemistry / Life Sciences / Biotechnology
Job Details:	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 Bioanalytical assay development. 2) Responsible for TK, PK, ADA & NAB assay development, and 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 an 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 bioanalytical test procedures (ATPs).
Regulatory Exposure:	Not Required
Experience:	8 -15 years
Last Date:	21/02/2023

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