Executive - Biotechnology

12 hours ago

Vadodara Gujarat, India Sun Pharmaceutical Industries Full time

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

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