Executive - Biotechnology

Sun Pharmaceutical Industries, Inc.; Vadodara; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc. is seeking a Senior Executive– Biotechnology in Vadodara to develop LC-MS–based methods for protein characterization and to qualify them for pipeline products.

The role involves integrating chromatography with mass spectrometry to assess variants and impurities across global batches. The candidate will design advanced workflows for PTMs and disulfide analysis, prepare MDRs and ATPs, and ensure GLP compliance while supporting regulatory queries and dossier

Qualifications

• MSc or M.Tech in Biotechnology or Biochemistry is required.
• 4–7 years of relevant industry experience is required.
• Experience with GLP regulations and regulatory documentation is preferred.

Responsibilities

• Develop LC-MS based methods for protein and peptide characterization.
• Qualify the methods for intended purpose for pipeline products.
• Design integrated strategies linking chromatography and mass spectrometry for qualitative and quantitative assessment of variants and impurities; prepare target profiles.
• Develop advanced workflows such as multi-attribute methods for PTMs and sequence variants; profile HCPs and disulfide bond analysis.
• Prepare and review method development reports (MDR) and analytical test procedures (ATP).
• Operate and maintain analytical laboratories in compliance with GLP; maintain MS instruments.
• Manage chemicals, consumables and reagents inventory; calibrate instruments; troubleshoot issues.
• Draft technical content for regulatory dossiers.

Skills

Analytical skills

LC-MS knowledge

Education

MSc or M.Tech in Biotechnology or Biochemistry

Tools

LC-MS

CEX-MS

SEC-MS

HPLC

Job description

Job Title:

Senior Executive– Biotechnology

Business Unit:

R&D1 Regulatory Affairs

Job Grade

G11B

Location:

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

• 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).
• 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.
• The candidate is expected to draft the technical content for regulatory dossier.

NA

Job Requirements

Educational Qualification

• MSc or M.Tech in Biotechnology or Biochemistry

Experience

Master's degree (M.Sc./M.Tech.) in Biotechnology, Biochemistry, Pharmaceutical Sciences, or a related discipline with 4-7 years of relevant industry 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).