Job Title:

Manager - Biotechnology

Business Unit:

R&D1; Regulatory Affairs

Job Grade

G10

Location:

Vadodara

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a cooperative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

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.
- Lead the evaluation of innate immune responses associated with therapeutic peptides and proteins.




- Lead the assessment of adaptive immune responses associated with therapeutic peptides and proteins
- 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.

Travel Estimate

NA

Job

📌 Manager -1 Biotechnology (India)
🏢 Sun Pharmaceutical
📍 India