**Job Title:** Executive/Sr Executive Biotechnology (Protein Characterization) **Business Unit:** R&D1 Regulatory Affairs **Job Grade** G12A / G11B **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, youll 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 others journeys. **Job** **Job Description** + The candidate is expected to develop HPLC based methods for protein and peptide products. + The candidate is expected to develop CE based methods for protein and peptide products. + Responsible for analytical method qualification for all pipeline products. + Characterization of innovator product batches sourced from different geographical region and preparation of quality target profile. + Analytical similarity assessment of in-house products. + 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 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. **T/TTechnical Skills** + Sound knowledge of analytical method development, qualification and structural and functional characterization of therapeutic proteins. + Experience of biosimilarity assessment of biologics for regulated market is desirable. + Experience of analytical development for monoclonal antibodies and peptide is highly desirable. **Travel Estimate** NA **Job Requirements** **Educational Qualification** M.Sc/M.Tech in Biology **Experience** _Tenure_ : 2-6 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. Lets 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)._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.