Sr Scientist, LCMS

Abzena Inc.•Bristol, PA

About The Position

Abzena is seeking an experienced LC-MS scientist to develop LC-MS methods for conjugate characterization supporting process development of antibody-drug conjugates (ADCs), oligonucleotide conjugates, radioconjugates, and other complex bioconjugate modalities. The scientist will serve as a technical expert in mass spectrometry-based characterization and method development across process development and CMC activities. The role develops and implements advanced LC-MS workflows for structural characterization, impurity analysis, linker-payload assessment, DAR determination, peptide mapping, and comparability studies supporting clinical development programs. The position works cross-functionally with process development, bioassay, formulation, and quality teams, and contributes to technical and regulatory documentation.

Requirements

  • Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline with 0 years of industry experience; or an M.S. with 2 or more 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 and 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.

Nice To Haves

  • 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.

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 and 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 with process development, bioassay, formulation, and quality teams to establish analytical control strategies and critical quality attributes (CQAs).
  • Develop 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 preventive maintenance and vendor repair services.

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What This Job Offers

Job Type

Full-time

Career Level

Senior

Education Level

Ph.D. or professional degree

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