Senior / Principal Scientist, LCMS - ADC & Related Modalities
AbzenaAbout the role
We are seeking an experienced LC-MS scientist to lead LC-MS method development and conjugate characterization activities supporting process development of antibody-drug conjugates (ADCs), oligonucleotide conjugates, radioconjugates, and other complex bioconjugate modalities. This individual will serve as a technical expert in mass spectrometry-based characterization and method development across process development and CMC activities.
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, qualification, 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).
- Serve as technical SME for high-resolution mass spectrometry platforms including QTOF, triple quadrupole, and associated LC systems.
- Develop robust sample preparation workflows for proteins, peptides, oligonucleotides, and conjugated modalities.
- 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.
- Evaluate and implement emerging MS technologies and analytical innovations to enhance characterization capabilities.
- 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.
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 met
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