Research Scientist _ Analytical Development (Biologics)

Role & responsibilities

• Analytical testing:

  Conduct a wide range of tests, including biochemical assays (Spectroscopic), Immunochemical assay (ELISA, Western blotting), DNA quantification (RT-PCR) and various chromatographic techniques (e.g., SEC, RP, SDS-PAGE,).

• Method development and validation:

  Assisting in or leading the development, optimization, and validation/qualification of analytical methods for the characterization of biosimilars and other large molecules.

• Biosimilarity studies :

  Perform studies to compare the biosimilar candidate to the reference product, focusing on physicochemical, functional, and safety properties.

• Statistical Data analysis and reporting:

  Processing and interpreting data, drawing conclusions, and generating reports for regulatory submissions and internal decision-making.

• Equipment and compliance:

  Maintain and calibrate lab equipment, ensure compliance with Good Laboratory Practices (GLP) and Data Integrity (DI), and handle documentation.

• Troubleshooting & Investigations:

  Assisting in troubleshooting technical and scientific problems and supporting laboratory investigations (e.g., Lab incidence).
• Working with cross-functional teams including Process development (upstream/downstream), Quality control (QC), Quality Assurance (QA), and Regulatory affairs (RA).

Preferred candidate profile

• Proficiency in techniques like RT-PCR, DNA Hybridization, Electrophoresis: SDS-PAGE, Western blotting, Capillary Electrophoresis (CE), Spectrophotometry & Immunoassays: Colorimetric/spectrophotometric assays (e.g., BCA, Bradford), ELISA (Enzyme-Linked Immunosorbent Assay), UV-Vis spectroscopy. Chromatography: SEC (Size Exclusion Chromatography), IEX (Ion Exchange Chromatography), RP (Reverse Phase Chromatography), HPLC, UPLC.
• Education: Requires a Master's or Ph.D degree in a life science, Biotechnology, Biochemistry, or Pharmaceutical Science..
• Experience: 5-8 years of hands-on experience in analytical development or quality control, preferably with biologics like large molecules.