Senior Principal Scientist (Toxicology)

Location: Thousand Oaks, California, United States; hybrid, with remote work potentially available.

Annual salary range: $168,392.65–$227,825.35 USD.

Company

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

What you will do

• Develop toxicological assessments for leachable and extractable substances from single-use manufacturing materials, drug containers, delivery devices, and combination products.
• Support biocompatibility evaluations for medical devices, including ISO 10993-1 and ISO 10993-17 assessments.
• Assess process reagents, excipients, product quality issues, non-conformances, and product complaints.
• Conduct patient and worker safety risk assessments, including Occupational Exposure Band and GHS hazard classifications.
• Derive Occupational Exposure Limits and document findings in product Hazard Assessment Monographs.
• Conduct literature and regulatory research and coordinate EHSS contributions to initiatives including ICH M7 and EU GMP updates.

Requirements

• PhD, PharmD, or MD with 2 years of toxicology experience; or a master’s degree with 5 years; or a bachelor’s degree with 7 years of toxicology experience.
• Experience in toxicology, hazard assessment, and risk assessment within the pharmaceutical or biopharmaceutical industry.
• Knowledge of leachable and extractables studies, packaging and device material characterization, and risk-based toxicology assessments.
• Working knowledge of medical-device biocompatibility evaluations and pharmaceutical development.
• Strong scientific writing, research, communication, presentation, project management, and operational excellence skills.
• Experience with toxicology, regulatory, and literature databases and computational tools such as OECD Toolbox, Toxtree, and Benchmark Dose.

Nice to have

• MS or PhD in toxicology, pharmacology, or a related health science.
• Toxicology board certification such as DABT or ERT.
• Knowledge of PQRI, BPOG, ICH, ISO, ICH M7 TTC, Cramer TTC, and Permissible Daily Exposure values.
• Experience with EndNote or equivalent and Microsoft Office.

Culture & Benefits

• Collaborative, innovative, science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plan with company contributions, stock-based long-term incentives, and an annual bonus program.
• Paid time-off plans and career development opportunities.
• Flexible work models where applicable.

Hiring process

• Applications are accepted until hirify.global receives a sufficient number of applications or selects a candidate.
• Sponsorship for this role is not guaranteed.