Senior Scientist, Biologics Analytics & ADCs

Exelixis; Alameda (CA); On-site; USD 128,000 - 181,000; Full time

Benefits offered by this job

401k plan with company contributions

Medical, dental, and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus program

Stock purchase opportunities

Vacation and holidays

Job summary

Exelixis is seeking a Senior Scientist, Analytical Development, Biologics CMC in Alameda, CA to advance analytical methods and characterize biologics using high‑resolution mass spectrometry and LC‑MS workflows. The role is hands‑on in the lab with cross‑functional collaboration to support pre‑IND and clinical programs.

The candidate will lead or support assay development for ADCs and related biologics, transfer methods to CDMOs, and contribute to regulatory submissions.

Qualifications

• Ph.D. in a relevant field with industry experience or M.S. with 5+ years experience.
• Hands-on experience in protein characterization using high‑resolution mass spectrometry (Orbitrap/Q‑TOF).
• Strong LC‑MS/MS workflows for intact protein, reduced/subunit, peptide mapping and PTM analysis.
• Experience in analytical assay development for ADCs (SEC, HIC, RP‑HPLC, icIEF, CE‑SDS, DAR analysis).
• Excellent scientific writing and ability to work cross-functionally with CDMOs/CTLs.

Responsibilities

• Act as SME for HRMS-based protein characterization of biologics, including ADCs and bispecifics.
• Develop, optimize, and execute LC‑MS methods for intact mass, reduced mass, and subunit analysis.
• Lead or support assay development for biologics (SEC, HIC, RP‑HPLC, icIEF, CE‑SDS, DAR).
• Support ADC characterization including conjugation site analysis and DAR distribution.
• Transfer analytical methods to CDMOs/CTLs and oversee method qualification/validation.
• Review GMP release and stability data; support OOS/OOT, deviations, and change control.
• Author and review analytical procedures, SOPs, and regulatory documents.
• Collaborate with Process Development, DS/DP Manufacturing, QA, Regulatory, and external partners.
• Maintain internal capabilities for advanced biologics characterization and instrument operation.

Skills

Protein characterization

Mass spectrometry

LC-MS/MS

Biologics analytics

ADC analysis

Analytical method development

Data interpretation

Cross-functional collaboration

Technical writing

Regulatory documentation

Education

Ph.D. in chemistry/biochemistry/analytical chemistry

M.S. in related field with 5+ years experience

B.S. in related field with 7+ years experience

Equivalent education/experience

Tools

Orbitrap mass spectrometers

Q-TOF

SEC

HIC

RP-HPLC

icIEF

CE-SDS

Job description

Exelixis is seeking a Senior Scientist, Analytical Development, Biologics CMC in Alameda, CA to advance analytical methods and characterize biologics using high‑resolution mass spectrometry and LC‑MS workflows. The role is hands‑on in the lab with cross‑functional collaboration to support pre‑IND and clinical programs.

The candidate will lead or support assay development for ADCs and related biologics, transfer methods to CDMOs, and contribute to regulatory submissions.