Analytical Manager (Biosimilars)

Job highlights

• M.Sc./M.Pharm/M.Tech/Ph.D. in Life Sciences with 3-10 years in biopharmaceutical analytical R&D; expertise in chromatography, mass spectrometry, electrophoresis
• Lead physicochemical characterization, develop and validate analytical methods, troubleshoot equipment, conduct comparability assessments, ensure cGMP/GLP compliance

Relocation Note: This position is based in Ahmedabad. Candidates must be willing to relocate to Ahmedabad, Gujarat.

We are looking for a dynamic and technically proficient Analytical Manager / Senior Analyst to lead advanced analytical operations for our biopharmaceutical and biosimilar pipeline. In this role, you will be responsible for conducting rigorous physicochemical characterization of complex biosimilar products using state-of-the-art analytical instrumentation. You will also spearhead the lifecycle of analytical methodsfrom initial development and optimization to qualification, troubleshooting, and comprehensive comparability assessments.

Key Responsibilities

• Physicochemical Characterization: Perform in-depth structural, chemical, and physical characterization of biosimilar products utilizing cutting-edge analytical techniques.
• Method Development & Optimization: Design, develop, optimize, and validate robust analytical methods for product release, characterization, and stability studies.
• Troubleshooting & Qualification: Qualify analytical equipment and troubleshoot complex method or instrument failures to ensure uninterrupted laboratory operations and compliance.
• Comparability & Data Assessment: Execute and document comparability assessments to support process changes, manufacturing site transfers, and regulatory submissions.
• Documentation & Compliance: Maintain stringent documentation standards in alignment with cGMP, GLP, and regulatory guidelines, preparing protocols, reports, and standard operating procedures (SOPs).

Key Requirements & Qualifications

• Education: M.Sc., M.Pharm, M.Tech, or Ph.D. in Biotechnology, Biochemistry, Analytical Chemistry, or related Life Sciences.
• Experience: 3 to 10 years of hands-on analytical R&D or QC experience within the biopharmaceutical, biosimilars, or life sciences industry.
• Technical Expertise: Strong theoretical and practical knowledge of chromatography (HPLC/UPLC), mass spectrometry (LC-MS/MS), electrophoresis, spectroscopy, and method validation principles.