Senior Executive

1 week ago

Vadodara, Gujarat, India SUN PHARMA 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.

*Routine & Stability Testing*

  • 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

*Instrument Operation & Maintenance*

  • 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.

*Documentation & Compliance*

  • 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.

*Quality & Regulatory Compliance*

  • Participate in internal and external audits, and support regulatory submissions with analytical data.

*Cross-functional Collaboration*

  • 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.

*Training & Development*

  • Train junior analysts and new team members on analytical techniques and laboratory practices.
  • Stay updated with advancements in analytical technologies and regulatory expectations.

Qualifications & Experience

  • 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.

Key Skills

  • 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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