Senior Scientist I - Analytical Development, Biologics CMC (Biologics)

Location: Alameda, California, United States; primarily laboratory or office-based

Salary: $127,500–$180,500 annually

Company

hirify.global develops medicines and supports biologics programs from pre-IND through clinical development.

What you will do

• Serve as a subject matter expert in high-resolution mass spectrometry-based characterization of biologics, including ADCs, monoclonal antibodies, and bispecific antibodies.
• Develop, optimize, qualify, and transfer LC-MS, chromatography, electrophoresis, and other analytical methods.
• Characterize intact and subunit proteins, peptide maps, post-translational modifications, glycosylation, sequence variants, disulfide bonds, and chromatographic peaks.
• Support ADC characterization, including conjugation sites, drug-antibody ratio distribution, linker-payload variants, impurities, and degradation products.
• Provide technical oversight to CDMOs and CTLs for method qualification, validation, routine testing, and analytical investigations.
• Contribute to CQA assessment, control strategy development, regulatory submissions, laboratory capabilities, and cross-functional CMC activities.

Requirements

• Ph.D. in chemistry, biochemistry, analytical chemistry, pharmaceutical sciences, chemical engineering, protein chemistry, or a related field with relevant industry experience; or a relevant master's degree with 5+ years or bachelor's degree with 7+ years of industry experience.
• Hands-on experience with protein characterization and structural elucidation using high-resolution mass spectrometry, including Orbitrap or Q-TOF systems.
• Strong experience with LC-MS/MS workflows for intact protein and subunit analysis, peptide mapping, PTM and glycan analysis, disulfide mapping, sequence confirmation, and variant characterization.
• In-depth knowledge of biologics analytical development, protein chemistry, mass spectrometry, chromatography, electrophoresis, and CMC product characterization.
• Ability to design studies, interpret complex analytical data, prepare technical and regulatory documentation, and collaborate with internal teams and external partners.
• Ability to work primarily in a laboratory or office environment in Alameda, California, with exposure to hazardous materials and extreme cold.

Nice to have

• Experience developing analytical assays for ADCs using SEC, HIC, RP-HPLC, icIEF, CE-SDS, DAR-related analysis, and residual-free drug analysis.
• Experience with higher-order structure analysis using SEC-MALS, DSC, FTIR, or CD.

Culture & Benefits

• Cross-functional work in a fast-paced, matrixed environment with internal teams, CDMOs, CTLs, and other partners.
• Comprehensive medical, dental, and vision coverage, life and disability insurance, flexible spending accounts, and a 401(k) plan with company contributions.
• Annual discretionary bonus eligibility, stock purchase opportunities, and long-term incentives.
• Fifteen accrued vacation days in the first year, seventeen paid holidays, a company-wide winter shutdown, and up to ten sick days annually.
• Modern office facilities with dual monitors, ergonomic chairs, and collaborative workspaces.