Sr. Principal Scientist - Immunogenicity Bioanalytical Sciences (Biotech)

Location: Thousand Oaks, California, United States

Company

hirify.global develops and manufactures biotechnology medicines across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead the design, development, validation, transfer, and implementation of immunogenicity assays for nonclinical and clinical programs.
• Develop and oversee ADA, NAb, drug-tolerant, cell-based, and predictive immunogenicity assay approaches.
• Apply global regulatory guidance, GLP/GCP expectations, and statistical validation principles to program decisions.
• Interpret complex data, troubleshoot assay issues, and conduct risk assessments for immunogenicity strategies.
• Provide scientific oversight for assay transfers to global bioanalytical CROs and support regulatory filing responses.
• Influence cross-functional teams and senior stakeholders while mentoring scientists and supporting capability building.

Requirements

• Doctorate in biochemistry, molecular biology, cell biology, immunology, or a related field plus 3 years of scientific or technical industry experience; or a master’s degree plus 6 years; or a bachelor’s degree plus 8 years.
• Expertise in developing, validating, and overseeing immunogenicity assays for anti-drug binding and neutralizing antibodies.
• Experience with GLP and knowledge of GCP guidelines, statistical approaches, assay troubleshooting, and data interpretation.
• Experience transferring immunogenicity assays to bioanalytical CROs and working in matrixed, cross-functional environments.
• Strong project management, communication, collaboration, and multitasking skills.
• Ability to work at the Thousand Oaks, California, United States corporate headquarters.

Nice to have

• Knowledge of drug-tolerant, cell-based, and predictive immunogenicity assay formats.
• Supervisory or mentoring experience in a laboratory setting.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Paid time off and career development opportunities.