Sr Scientist, LCMS

The successful candidate will play a key role in developing and implementing advanced LC-MS workflows for structural characterization, impurity analysis, linker-payload assessment, DAR determination, peptide mapping, and comparability studies to support clinical development programs.

Responsibilities

• Lead development, optimization, and transfer of LC-MS analytical methods supporting ADCs and related bioconjugate therapeutics.
• Design and execute mass spectrometry studies for characterization of intact proteins/antibodies, fragment antibodies, small format proteins, peptides, linker-payloads, oligonucleotides, and conjugated species.
• Perform characterization activities including DAR analysis, peptide mapping, PTM identification, conjugation site analysis, aggregation and fragmentation assessment, disulfide scrambling, free payload and linker impurity analysis, and stability studies.
• Support analytical investigations related to process development, manufacturing deviations, comparability, and product quality assessments.
• Collaborate closely with process development, bioassay, formulation, and quality teams to establish analytical control strategies and critical quality attributes (CQAs).
• Develop robust sample preparation workflows for proteins, peptides, oligonucleotides, and conjugated modalities for LC-MS analyses.
• Interpret complex analytical datasets and communicate findings to cross-functional project teams and client sponsors.
• Author technical reports, analytical development summaries, regulatory documentation, SOPs, protocols, and method qualification reports.
• Support regulatory submissions including IND, BLA, and IMPD analytical sections.
• Maintain instrumentation including general maintenance, troubleshooting and scheduling of performative maintenance and vendor repair services.

Qualifications

• Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with 0 years of industry experience; or M.S. with 2+ years of relevant experience.
• Extensive hands-on experience with LC-MS characterization of biologics, ADCs, or related conjugated therapeutics.
• Hands-on experience with high-resolution mass spectrometry techniques and interpretation of complex datasets.
• Experience with analytical characterization techniques including intact/reduced, subunit mass analysis, and peptide mapping.
• 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.

Preferred Qualifications

• Experience specifically supporting ADCs, AOCs, radioconjugates, or oligonucleotide therapeutics.
• Familiarity with linker-payload chemistry and conjugation process development.
• Experience with multi-attribute methods (MAM) and advanced characterization workflows.
• Knowledge of regulatory expectations for biologics and conjugated therapeutics.
• Experience supporting method qualification, validation, and comparability studies.
• Demonstrated experience supporting CMC development and CGMP environments.
• Prior experience working with CDMOs and external analytical laboratories.