Senior Executive / Manager 2
SUN PHARMA
Date: 2 weeks ago
City: Vadodara, Gujarat
Contract type: Full time
Key Responsibilities: Analytical Method Development & Validation
- Develop and validate robust HPLC methods for characterization and quantification of biological products (e.g., monoclonal antibodies, recombinant proteins).
- Perform method optimization, robustness studies, and transfer protocols as per ICH guidelines.
- Conduct analysis of in-process, release, and stability samples using:
- HPLC/UPLC
- Capillary and Gel Electrophoresis
- UV spectrophotometric methods
- Host Cell DNA quantification (e.g., qPCR-based methods)
- HCP ELISA and other immunoassays
- Perform routine maintenance, calibration, and troubleshooting of analytical instruments including HPLC, electrophoresis systems, spectrophotometers, and ELISA readers.
- Ensure timely qualification and performance verification of instruments.
- Prepare and review SOPs, STPs, protocols, reports, and analytical records in compliance with regulatory requirements.
- Maintain accurate and complete documentation in laboratory notebooks and electronic systems.
- Participate in internal and external audits, and support regulatory submissions with analytical data.
- Work closely with R&D, Quality Control, and Regulatory Affairs teams to support product development and lifecycle management.
- Provide technical support during investigations, deviations, and CAPAs.
- Train junior analysts and new team members on analytical techniques and laboratory practices.
- Stay updated with advancements in analytical technologies and regulatory expectations.
- M.Sc. / M.Tech / M.Pharm in Biotechnology, Biochemistry, or related life sciences discipline.
- 4–8 years of relevant experience in analytical development or QC of biopharmaceuticals.
- Hands-on experience with HPLC method development and ELISA based techniques.
- Familiarity with regulatory guidelines (ICH, FDA, EMA) and quality systems.
- Strong analytical and problem-solving skills
- Attention to detail and data integrity
- Excellent documentation and communication abilities
- Proficiency in software tools like Empower, Chromeleon, SoftMax Pro, etc.
- Ability to manage multiple projects and meet deadlines
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