Senior Manager Fresher's job

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.

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Sun Pharmaceutical Industries Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients in more than 100 countries across the globe.