Job Description

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