Senior Scientist, Analytical Development - Large Molecule

Role: Senior Scientist in Large Molecule Analytical Development, focusing on biologics drug candidates.

Responsibilities include managing internal labs and overseeing CRO/CMDO analytical activities such as method development, qualification, transfer, and characterization of drug substances and products. The role supports release and stability testing, collaborates with multidisciplinary teams, and authorizes analytical documentation for regulatory submissions like INDs and CTAs.

Requirements:

PhD with 2+ years or Master’s with 4+ years or Bachelor’s with 6+ years in biopharma, with expertise in bioanalytical chemistry, chromatography, mass spectrometry, and biophysical techniques. Experience in biologics development, GxP, and regulatory guidelines is essential. Nice-to-have skills include bioinformatics, software development, and sequencing analysis.

Location: On-site in Bridgewater, NJ, with occasional domestic/international travel (~5-15%).

High-value aspects: biologics, large molecules, preclinical and clinical stages, analytical method development, regulatory documentation, cross-functional collaboration, and GxP environment.