Senior Executive / Manager 2

Job Title

Manager 2 – Biotechnology

Business Unit

R&D1 Regulatory Affairs

Job Grade

G11A

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 collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Job Description

• Lead bioanalytical method development, optimization, and validation of ligand-binding assays (ELISA, MSD, ECL, etc.) for quantification of biologics and ADA detection for biologics and biosimilars.
• Ensure adherence to regulatory guidance (FDA, EMA, ICH, OECD) for bioanalytical method validation and sample analysis.
• Design and validate ADA assays (screening, confirmatory, titration, and neutralizing antibody assays).
• Interpret and review ADA data to support immunogenicity assessments in clinical studies.
• Identify, evaluate, and qualify CROs for clinical bioanalytical activities.
• Maintain awareness of global regulatory requirements (FDA, EMA, WHO, DCGI) related to biologics/biosimilar bioanalysis.
• Support regulatory submissions, audits, and inspections.
• Prepare and review analytical documentation for regulatory submissions (IND, BLA, etc.) for biologics and biosimilars.
• Collaborate with cross-functional teams including Process Development, Quality Control, and Regulatory Affairs.
• Troubleshoot analytical issues and provide technical expertise during investigations.
• Prepare technical document and query responses from different agencies.
  
  

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Job Requirements

Educational Qualification

Graduate : M.Sc/M.Tech in Biotechnology/Biochemistry

Experience

Tenure : Minimum 8 - 10 years of experience

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).