Senior Scientist, Biologics Analytics & ADC Characterization

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

Benefits offered by this job

401k plan

Medical, dental & vision coverage

Life & disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock purchase program

Long-term incentives

Paid vacation days

Paid holidays

Sick days

Job summary

Exelixis is seeking a Senior Scientist in Analytical Development for Biologics CMC to advance mass spectrometry-based protein characterization and assay development for ADCs. You will work hands-on in the lab to develop, qualify, and transfer analytical methods supporting pre-IND and clinical programs.

You will partner with Process Development, manufacturing, QA, Regulatory, and external CDMOs to ensure rapid, cost-effective, high-quality CMC outputs and robust data packages for regulatory

Qualifications

• Hands-on experience with high-resolution MS for protein characterization.
• Experience with LC-MS/MS workflows for intact protein analysis and PTMs.
• Experience in analytical assay development for ADCs (SEC, HIC, RP-HPLC, icIEF, CE-SDS, DAR).
• Knowledge of biologics analytical development, RGBA attributes, and quality control considerations.

Responsibilities

• Serve as SME for MS-based protein characterization of biologics and related modalities.
• Develop, optimize, and execute LC-MS methods for intact mass, subunits, and PTMs.
• Lead or support assay development for biologics (SEC, HIC, RP-HPLC, icIEF, CE-SDS).
• Transfer analytical methods to CDMOs/CTLs and oversee qualification/validation.
• Review GMP release, stability data, and investigations related to analytical methods.

Skills

Mass spectrometry

LC-MS

Protein characterization

ADC characterization

Analytical method development

Data interpretation

Technical writing

Cross-functional collaboration

Project management

Education

Ph.D. in chemistry/biochemistry/analytical chemistry or related field

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

B.S./B.A. in related field with 7+ years industry experience

Tools

Orbitrap

Q-TOF

LC-MS/MS

SEC-MALS

DSC

FTIR

CD

icIEF

RP-HPLC

HIC

CE-SDS

DAR analysis

Job description

Exelixis is seeking a Senior Scientist in Analytical Development for Biologics CMC to advance mass spectrometry-based protein characterization and assay development for ADCs. You will work hands-on in the lab to develop, qualify, and transfer analytical methods supporting pre-IND and clinical programs.

You will partner with Process Development, manufacturing, QA, Regulatory, and external CDMOs to ensure rapid, cost-effective, high-quality CMC outputs and robust data packages for regulatory