R&D Analytical Development Lab, Biosimilars

Job Summary:

The ADL Scientist is responsible for delivering high-quality analytical data to support biotherapeutic product development. The role involves hands-on execution of various analytical techniques including chromatography and electrophoresis, with a focus on method development, qualification, and process support, ensuring compliance with regulatory and scientific standards.

Key Responsibilities:

1. Timely execution of analytical deliverables for biotherapeutic projects involving QTPP, process support, method development, qualification, and transfer.
2. Perform benchwork using diverse analytical techniques including colorimetric/spectrophotometric assays, chromatographic tests (SEC, IEX, HIC, RP), and electrophoresis (cIEF, CE-SDS NR & R, CE-LIF).
3. Independently plan, execute, and interpret experiments with sound scientific judgment.
4. Maintain accurate and timely documentation of all experimental results, protocols, and reports.
5. Prepare and review SOPs, MOAs, MDRs, and other technical documentation.
6. Ensure adherence to Good Laboratory Practices (GLP) and assist in maintaining lab discipline and documentation systems.
7. Support project teams with scientific input, report preparation, and presentations.

Skills and Competencies:

• Expertise in chromatographic techniques (SEC, IEX, HIC, RP) using HPLC/UPLC systems.
• Proficiency in electrophoretic methods such as cIEF, CE-SDS (Non-reducing & Reducing), CE-LIF.
• Hands-on experience in N-Glycan analysis and higher-order structure analysis is an advantage.
• Strong understanding of analytical method development and validation for biotherapeutics.
• Proficiency in MS Office and software tools linked to analytical instruments.
• Strong documentation and communication skills.

Educational Qualifications:

• M.Sc. Biotechnology

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  M.Tech. Biotechnology

Preferred Experience:

• 26 years of hands-on experience in a biopharmaceutical or analytical development environment.