Executive - Biotechnology (Baroda, IN) bei None

Job Title:

Executive – R&D Biotechnology  

Business Unit:

R&D1 Regulatory Affairs

Job Grade

G12A

Location

Baroda

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 HPLC based methods for protein and peptide products.

• The candidate is expected to design and implement integrated strategies, linking appropriate analytical tools, to perform a qualitative and quantitative assessment of product related variants and impurities. Develop and apply novel sample preparation with emphasis on RP-HPLC, SEC-HPLC, N-Glycan, CEX-HPLC etc.
• Responsible for designing advance workflows to measure & characterize process related impurities at different stages of product development such as Host cell protein (HCPs), Host Cell DNA (HCD) & Leachable.
• The candidate is expected to qualify the methods for intended purpose for all pipeline products.
• Responsible for routine in process sample analysis. 
• Responsible for preparation and review of method development reports (MDR), method qualification reports (MQR) and analytical test procedures (ATP).
• Responsible for operating and maintaining analytical laboratory in compliance with GLP regulations.
• 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

Graduate : M.Sc

Experience

Tenure: 2-4 years

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).