Sun Pharma is the fourth largest generic pharmaceutical company in the world It is also India's largest and most valuable pharmaceutical enterprise by size and market capitalization. The company provides high quality medicines trusted by customers and patients in over ISO countries and has multiple manufacturing facilities and R&D centers. Our leadership is approachable, recognizes people's passions for growth, gives them a voice and empowers them to make a positive change.
Post : Senior Manager
Key Responsibilities
• Work in close partnership with contract research organizations (CROs) for Bio analytical assay development.
• 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.
• 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.
• 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.
• 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.
• Work independently and in collaboration with a subject matter expert (SME) representative of the clinical & non-clinical group.
• Identification & screening of CROs for Bioanalytical services.
• Provide guidance to contract organizations (CROs) on assay development, experimental design, troubleshooting and sample analysis.
• Review of method development reports (MDRs), validation reports and bio analytical test procedures (ATPs).
• Responsible for managing the regulatory queries.
• The candidate is expected to draft the technical content for regulatory dossier.
Location : Tandalja - R&D
Last Date : 10th July, 2023
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