Sr Scientist - Analytical Development, Biologics CMC

SUMMARY/

JOB PURPOSE:

The Senior Scientist, Analytical Development, Biologics CMC will support CMC analytical development for biologic therapeutics, with a primary focus on protein characterization using high-resolution mass spectrometry and analytical assay development for antibody-drug conjugates (ADCs). The incumbent will apply deep technical expertise in mass spectrometry, liquid chromatography and electrophoresis to perform assay development and product characterization, and to advance pre-IND and clinical-stage biologics programs.

The individual is expected to work hands-on in the laboratory to develop, optimize, qualify, and transfer analytical methods supporting internal CMC development activities and external CDMO/CTL execution. This role will support extended characterization of ADCs, monoclonal antibodies, bispecifics, and other biologic modalities, including intact and subunit mass analysis, peptide mapping, post-translational modification assessment, sequence confirmation, conjugation site analysis, linker-payload related variant identification, DAR-related characterization, and chromatographic peak identification.

Strong ownership is critical to ensure the speed, cost-effectiveness, and technical quality of our CMC activities. The individual will work independently and in cross-functional teams, and work effectively with third-party CDMOs and partners.

• Serve as a subject matter expert for high-resolution mass spectrometry-based protein characterization of biologics, including ADCs, monoclonal antibodies, bispecific antibodies, and related novel biotherapeutic proteins.
• Develop, optimize, and execute LC-MS methods for intact mass, reduced and non-reduced mass analysis, subunit analysis, peptide mapping, PTM identification, sequence confirmation, disulfide mapping, glycosylation assessment, and product variant characterization.
• Lead or support assay development for biologics, including methods such as SEC, HIC, RP-HPLC, icIEF, CE-SDS, and residual-free drug analysis
• Support ADC-specific characterization, including conjugation site analysis, drug-antibody ratio distribution, linker-payload related variants, conjugatable impurities, payload-related degradation products, and process- or storage-related modifications.
• Perform method development and analytical testing to support upstream, downstream, bioconjugation, and formulation process development.
• Transfer analytical methods from internal development to CDMOs/CTLs and provide technical oversight for method qualification, validation, and routine testing.
• Review and author analytical procedures, SOPs, protocols, technical reports, method qualification/validation documents, and product characterization reports.
• Review GMP release and stability testing results, and support OOS/OOT, deviation, change control, and investigation activities related to analytical methods and product quality.
• Support CQA assessment and control strategy development by integrating analytical results from mass spectrometry, chromatography, electrophoresis, biophysical characterization, and functional assays.
• Support IND/IMPD and other regulatory submission activities, including authoring and reviewing analytical development, characterization, method validation, and control strategy sections.
• Collaborate closely with Process Development, DS and DP Manufacturing, Quality Assurance, Regulatory Affairs, Project Management, Discovery, external CDMOs, CTLs, and other partners.
• Contribute to building and maintaining internal laboratory capabilities for advanced biologics characterization, including instrument operation, maintenance, troubleshooting, and implementation of new technologies.
• Work independently and collaboratively in a…