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)
Vacancy posted 4 days ago
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