Exel
Sr Scientist I - Analytical Development, Biologics CMC
Alameda, CA · Senior
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DOL prevailing wage, 2026-27 wage year · Biological Technicians (19-4021) · San Francisco-Oakland-Fremont, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
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About the role
- Strong ownership is critical to ensure the speed, cost-effectiveness, and technical quality of our CMC activities.
- The base pay range for this position is $127,500 - $180,500 annually.
- The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.
Responsibilities
- 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.
- 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.
Requirements
- It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
- No direct people management responsibility is required.
Nice to have
- Demonstrated hands-on experience in protein characterization and structural elucidation using high-resolution mass spectrometry, such as Orbitrap and Q-TOF, is highly desired.
- Experience in analytical assay development for ADCs is strongly preferred, including SEC, HIC, RP-HPLC, icIEF, CE-SDS, DAR-related analysis, and residual-free drug analysis.
Skills
- Equivalent combination of education and experience.
- Strong technical writing skills for protocols, reports, SOPs, regulatory sections, and investigation summaries.
- Ability to work effectively with cross-functional internal teams and external CDMOs/CTLs.
- Excellent communication, presentation, collaboration, and problem-solving skills.
- Strong ownership, scientific curiosity, attention to detail, and commitment to technical excellence.
- Experience in higher order structure analysis, such as SEC-MALS, DSC, FTIR, and CD is a plus.
Compensation
- The base pay range for this position is $127,500 - $180,500 annually.
- The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.
Benefits
- The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
- Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.