Senior Executive Biotechnology

SUN PHARMA; Vadodara; On-site; INR 600,000 - 900,000; Full time

Job summary

Sun Pharma, Vadodara, invites applications for Senior Executive-Biotechnology in the R&D1 Regulatory Affairs unit. The role focuses on biosimilar product characterization with LC-MS based methods and integrated strategies to assess product variants and impurities.

The candidate should have M.Sc/M.Tech and 2–6 years of relevant experience. You will develop and qualify methods, draft MDR/ATP, and support regulatory dossiers in a GLP-compliant analytical laboratory.

Qualifications

• M.Sc or M.Tech in Biotechnology or allied disciplines.
• 2–6 years of relevant experience in biotechnology.
• Experience with biosimilar product characterization preferred.

Responsibilities

• Develop LC-MS based methods for protein and peptide product characterization.
• Qualify methods for pipeline products.
• Design and implement strategies linking chromatography and MS for variants and impurities; prepare quality target profiles.
• Develop advanced workflows like multi-attribute methods for PTMs and sequence variants.
• Prepare and review method development reports and ATPs.
• Perform in-depth LC-MS data analysis to support product development.
• Collaborate with upstream and downstream processes to provide analytics insights and maintain GLP compliance.
• Operate and maintain MS instruments.
• Manage chemicals, consumables inventory and calibrate equipment.
• Draft regulatory content for dossiers.

Education

M.Sc/M.Tech

Tools

LC-MS

Job description

Job Title

Senior Executive-Biotechnology

Business Unit

R&D1 Regulatory Affairs

Job Grade

G11B

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 Objective

SeaLooking for highly motivated candidate having technical expertise in Biosimilar product characterization.

Key Responsibilities

• The candidate is expected to develop LC-MS based methods for protein and peptide product characterization.
• The candidate is expected to qualify the methods for intended purpose for all pipeline products.
• The candidate is expected to design and implement integrated strategies, linking appropriate chromatography and mass spectrometry tools, to perform a qualitative and quantitative assessment of product related variants and impurities. Develop and apply novel sample preparation with emphasis on LC-MS, CEX-MS, SEC-MS Characterization of innovator product batches sourced from different geographical region and preparation of quality target profile.
• Responsible for designing advance workflows such as multi-attribute methods for PTMs, sequence variants, qualitative and quantitative profiling of HCPs, Disulfide shuffling and bond analysis, cell culture metabolite analysis, glycan analysis etc.
• Preparation and review of method development reports (MDR) and analytical test procedures (ATP).
• Perform in-depth data analysis of LC-MS results and interpret findings to support product development and quality assessments
• Work closely with upstream and downstream process development teams to provide analytical insights Responsible for operating and maintaining analytical laboratory in compliance with GLP regulations.
• The candidate is responsible for the operation and maintenance of the MS instruments
• To manage chemicals, consumables & critical reagents inventory. Performs calibration of instruments and equipment. Troubleshoots instrument performance and equipment issues.
• Responsible for managing the regulatory queries.
• The candidate is expected to draft the technical content for regulatory dossier.

Travel Estimate

NA

Job Requirements

Educational Qualification

M.Sc/M.Tech

Experience

2-6 years of relevant 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).