Senior Scientist, Analytical Development (Large Molecule)

About the role

We're seeking a Senior Scientist, Analytical Development (Large Molecule) to join our Analytical Development team. Reporting to the Senior Manager, Large Molecule Analytical Development, you'll manage the internal analytical laboratory and oversee analytical activities at CROs/CDMOs.

Responsibilities

• Manage method development, analytical testing, and method qualification initiatives.
• Develop and implement methodologies for the quantitation, characterization, and stability testing of drug substances and drug products.
• Lead hands-on experience and deep understanding of techniques like Peptide mapping, HPLC/UPLC (IEX, SE, RP), SEC-MALS, DLS, DSC, CD & CE-SDS, and impurity assays for HCP, residual Protein A, residual host cell DNA, Bioburden, and Endotoxin detection.
• Develop bio-analytical methods for testing and characterization of protein therapeutics, including ELISA, SPR, BLI, and various cell-based assays.
• Design and execute experiments to characterize biochemical and biophysical properties of protein therapeutics.
• Collaborate in protein engineering to optimize stability, solubility, and other critical properties.
• Evaluate, design, and perform method development and qualification employing phase-appropriate approaches at different stages of development.
• Manage authoring of analytical sections of INDs, CTAs, BLAs, health authority responses, and regulatory interactions.
• Interact with internal partners, CROs, and contract laboratories during the development of analytical methods, stability testing, and preparation or overview of technical transfer documents.
• Work closely with internal stakeholders to present scientific results to cross-functional teams.
• Serve as the analytical development SME for large molecules in internal and external cross-functional projects.
• Manage relationships with external vendors to learn and evaluate new and upcoming technologies, including scheduling lunch-and-learns.

Requirements

• B.S. in Chemistry or Biochemistry with 8 years of experience, M.S. with 6 years, or PhD with 3 years in the biopharmaceutical industry.
• Hands-on experience using and interpreting data from various analytical techniques including chromatography, mass spectroscopy, SEC-MALS, and MS.
• Strong statistical skills with a good understanding of basic and intermediate statistical tests.
• Good understanding of GxP, CMC, ICH, and compendial (USP/EP/JP) regulatory requirements.
• Excellent presentation skills both verbally and in writing.
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Accurate, detailed, and timely notebook records of method development and analytical data.
• Knowledge of laboratory safety and quality control practices.