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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

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…