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Principal Toxicologist

Scorpion Therapeutics

Principal Toxicologist, Toxicology & Biocompatibility, R&D – MedTech (Flex/Hybrid; 3 days/week on-site; no remote). Based within commutable distance of Raritan, NJ (strongly desired) or Cincinnati, OH. You Will Be Responsible For: Evaluate medical device products/materials for biological safety per global regulations/standards, GLP (US FDA), and internal procedures. Design/initiate/coordinate/interpret biocompatibility and toxicology laboratory investigations. Apply technical expertise to resolve ISO 10993 biocompatibility issues and regulatory requirements. Coordinate biocompatibility test strategies, review documentation, and ensure deliverables completion. Review/interpret/summarize testing data; support risk assessment documentation. Provide technical guidance to internal/external partners across the product lifecycle. Support regulatory/notified body requests; directly interact with notified bodies (e.g., TUV, BSI). Identify/evaluate risks and drive resolution; participate in continuous improvement. Follow health, safety, and environmental (HSE) practices; ensure compliance (and supervise subordinates’ HSE compliance if applicable). Qualifications/Requirements: MS or PhD in Toxicology (or related); required. 6+ years relevant medical device industry. 8–10 years in toxicology/biocompatibility assessments (medical device/pharma/consumer); medical device experience strongly preferred. Regulated environment experience supporting submissions/audits; worldwide registration support preferred. Experience with absorbable biomaterials for implantable devices (degradation/toxicokinetics); required. Knowledge of ISO 10993 biocompatibility/toxicology assessment and relevant standards; required. Familiarity with ISO 13485, ISO 10993, ISO 14971, and design control. Strongly preferred: lab animal care & use; manufacturing process understanding. Required/Preferred Skills: Team collaboration, conflict resolution, technical leadership/mentorship. Strong written/verbal communication; proactive problem-solving. Travel up to 10%. Benefits (time off): Vacation (120h/yr) Sick time (40h/yr; CO/Washington adjustments) Holiday pay (13 days/yr) Personal/Family time (up to 40h/yr) Parental leave (480h) Bereavement (240h immediate/40h extended) Caregiver leave (80h) Volunteer leave (32h) Military spouse time-off (80h) #J-18808-Ljbffr Scorpion Therapeutics

Vacancy posted 2 days ago
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