Principal Scientist - Therapeutic Antibody Characterization
BioSpace · Berkeley, CA · 1 mo ago
AnalystFull-time
About the role
We are seeking an experienced Principal Scientist – Therapeutic Antibody Characterization to join our Therapeutics team. The successful candidate will lead the analytical characterization of monoclonal antibodies, bispecific antibodies, Fc-fusion proteins, and other complex biologics to support candidate selection and preclinical development. This role will apply a broad range of biochemical, biophysical, and analytical techniques to evaluate protein quality, developability, stability, and structure, while working closely with Antibody Discovery, Protein Engineering, and CMC teams.
Responsibilities
- Perform comprehensive analytical characterization of therapeutic monoclonal antibodies (mAbs), bispecific antibodies, Fc-fusion proteins, and related biologics.
- Conduct biophysical and developability assessments using techniques including Tm, Tagg (Uncle), particle size analysis, AC-SINS, HIC, cIEF, analytical SEC (aSEC), and BVP assays.
- Generate, analyze, and interpret analytical data to support lead candidate selection, formulation development, stability studies, and analytical comparability assessments.
- Design, execute, troubleshoot, and optimize analytical methods to support therapeutic protein characterization.
- Prepare clear, accurate, and well-organized technical reports and present experimental findings to cross-functional project teams.
- Collaborate closely with scientists in Antibody Discovery & Protein Engineering
- Maintain accurate laboratory documentation and ensure compliance with laboratory safety and quality standards.
Requirements
- Ph.D. or M.S. in Biochemistry, Chemistry, Molecular Biology, Pharmaceutical Sciences, or a related discipline.
- Minimum of 3 years of industry experience (or equivalent) in the analytical characterization of therapeutic antibodies, bispecific antibodies, Fc-fusion proteins, or other biologics.
- Strong hands-on experience with protein characterization techniques, including Tm, Tagg (Uncle), AC-SINS, HIC, cIEF, analytical SEC (aSEC), BVP, and related biochemical and biophysical assays.
- Demonstrated ability to independently design experiments, analyze data, solve technical challenges, and communicate scientific findings effectively.
- Excellent organizational, interpersonal, and written communication skills, with the ability to work effectively in a collaborative, multidisciplinary environment.
Qualifications
- Experience with antibody developability, stability profiling, and analytical comparability studies.
- Experience with LC-MS-based characterization of therapeutic antibodies, including intact mass analysis, subunit analysis, peptide mapping, and post-translational modification (PTM) analysis.
- Experience in the bioanalysis of serum and plasma samples to support pharmacokinetic (PK), pharmacodynamic (PD), and preclinical studies.
- Experience with the analytical characterization of antibody–peptide drug conjugates, including conjugation analysis, conjugate purity, drug loading, and stability assessment.
- Knowledge of regulatory expectations and analytical strategies supporting therapeutic biologics development.
Benefits
- A competitive employee benefits package, including group medical, dental, and vision coverage, life and disability insurance, flexible spending accounts, and a 401(k) plan
- Stock-based long-term incentives
- Holiday package including a 1+ week winter shutdown
- Flexible work models, including remote and hybrid working arrangements, where possible