Senior Executive Biotechnology

Sun Pharmaceutical Industries, Inc.; Vadodara; On-site; INR 700,000 - 1,200,000; Full time

Job summary

Sun Pharma is seeking a Senior Executive-Biotechnology in Vadodara to advance biosimilar product characterization. You will develop LC-MS based methods for protein and peptide characterization and qualify these methods for all pipeline products, ensuring robust analytical workflows.

You will design integrated strategies using chromatography and MS tools to assess product variants and impurities, perform advanced data analysis, and draft MDR/ATP documentation.

Qualifications

• M.Sc/M.Tech in a relevant field.
• 2-6 years of relevant experience.
• Experience in biosimilar product characterization is desirable.

Responsibilities

• Develop LC-MS based methods for protein and peptide product characterization.
• Qualify methods for intended purpose for all pipeline products.
• Design and implement integrated strategies linking chromatography and MS tools for qualitative and quantitative assessment of product variants and impurities.
• Develop and apply sample preparation with emphasis on LC-MS, CEX-MS, SEC-MS for characterisation of innovator product batches from different regions.

Education

M.Sc/M.Tech

Tools

LC-MS

CEX-MS

SEC-MS

Job description

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Company: Sun Pharmaceutical Industries Ltd

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 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.

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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).