Sun Pharma is hiring an Executive– Biotechnology for its R&D1 Regulatory Affairs business unit in Vadodara. This role is suitable for candidates with a strong background in biotechnology, biochemistry, pharmaceutical sciences, or a related discipline, along with relevant industry experience in LC-MS based analytical method development and product characterization.
| Company | Sun Pharma |
| Position | Executive– Biotechnology |
| Business Unit | R&D1 Regulatory Affairs |
| Department | Research and Development |
| Job Grade | G12A |
| Location | Vadodara |
| Experience | 2-5 years |
The selected candidate will work on protein and peptide product characterization, analytical method qualification, advanced workflows, regulatory documentation, and laboratory operations in compliance with GLP regulations.
Key Responsibilities
- Develop LC-MS based methods for protein and peptide product characterization.
- Qualify analytical methods for the intended purpose for all pipeline products.
- Design and implement integrated strategies using appropriate chromatography and mass spectrometry tools for qualitative and quantitative assessment of product-related variants and impurities.
- Develop and apply novel sample preparation approaches with emphasis on LC-MS, CEX-MS, and SEC-MS.
- Characterize innovator product batches sourced from different geographical regions and prepare quality target profiles.
- Design advanced 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, and related areas.
- Prepare and review method development reports (MDR) and analytical test procedures (ATP).
- Operate and maintain the analytical laboratory in compliance with GLP regulations.
- Handle operation and maintenance of MS instruments.
- Manage chemicals, consumables, and critical reagents inventory.
- Perform calibration of instruments and equipment, and troubleshoot instrument performance and equipment issues.
- Manage regulatory queries.
- Draft technical content for regulatory dossiers.
Qualification
- MSc or M.Tech in Biotechnology or Biochemistry.
- Master’s degree (M.Sc./M.Tech.) in Biotechnology, Biochemistry, Pharmaceutical Sciences, or a related discipline.
Experience
Candidates should have 2-5 years of relevant industry experience.
Benefits
Sun Pharma states that it provides robust benefits and opportunities to foster personal and professional growth.
How to Apply
Interested candidates can apply online through the official Sun Pharma careers link given below.