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 Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over US$ 4.5 billion. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe.