Principal Scientist, Project Toxicologist (Immunogenicity)

Location: United States; corporate headquarters in Thousand Oaks, California, with Washington, D.C. also listed in the posting.

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead immunogenicity assay development, validation, transfer, and implementation across nonclinical and clinical programs.
• Provide scientific expertise in ADA, NAb, drug-tolerant, cell-based, and predictive immunogenicity assays.
• Apply global regulatory guidance, GLP/GCP expectations, and statistical validation principles to program decisions.
• Interpret complex data, troubleshoot assays, assess risks, and support immunogenicity bioanalytical strategies.
• Oversee assay transfers to global bioanalytical CROs and contribute to regulatory filing responses.
• Influence cross-functional teams while mentoring scientists and supporting capability building.

Requirements

• Doctorate in biochemistry, molecular biology, cell biology, immunology, or a related field plus 3 years of relevant 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, knowledge of GCP, regulatory guidelines, statistical assay validation, and data interpretation.
• Experience transferring immunogenicity assays to bioanalytical CROs and working in matrixed, cross-functional environments.
• Project management, communication, collaboration, multitasking, and independent working skills.
• Supervisory or mentoring experience in a laboratory setting.

Culture & Benefits

• Collaborative, innovative, science-based working environment.
• Employee health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus program, stock-based long-term incentives, and award-winning time-off plans.
• Flexible work models where applicable, plus career development opportunities.

Hiring process

• Applications are accepted until a suitable candidate is selected; no fixed deadline is specified.
• Visa sponsorship is not guaranteed.