Senior / Principal Scientist, LCMS - ADC & Related Modalities
On-siteBristol, Pennsylvania, United States
Job Summary
Senior/Principal Scientist, LC-MS for ADCs and related bioconjugates. Lead LC-MS method development, conjugate characterization, and transfer across process development and CMC. Design and execute experiments for intact proteins/antibodies, fragments, peptides, linker-payloads, and conjugates. Perform DAR analysis, peptide mapping, PTMs, conjugation site analysis, aggregation/fragmentation assessment, and impurity analysis. Support process development, manufacturing deviations, comparability, and product quality assessments. Collaborate with PD, bioassay, formulation, and quality teams to establish analytical control strategies and CQAs. Serve as SME for HRMS platforms (QTOF, triple quadrupole) and develop robust sample prep workflows. Interpret complex datasets, author technical/regulatory documents, and support IND/BLA/IMPD submissions. Mentor junior scientists and contribute to scientific strategy and laboratory best practices.
Required Qualifications
- Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with 5+ years of industry experience; or M.S. with 8+ years of relevant experience.
- Extensive hands-on experience with LC-MS characterization of biologics, ADCs, or related conjugated therapeutics.
- Strong expertise in high-resolution mass spectrometry techniques and interpretation of complex datasets.
- Experience with analytical characterization techniques including intact mass analysis, peptide mapping, IEX, SEC, RP-HPLC, CE, and native MS.
- Demonstrated experience supporting CMC development and CGMP environments.
- Strong understanding of protein chemistry, conjugation technologies, and biopharmaceutical analytical development.
- Experience with data analysis software such as Waters Connect, MassLynx, or equivalent platforms.
- Excellent technical writing, problem-solving, and communication skills.
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