Principal Toxicologist
Johnson & Johnson
August 13, 2026
Remote friendly (Cincinnati, OH)
United States
Clinical Research and Development
Principal Toxicologist, Toxicology & Biocompatibility (R&D - MedTech)
Responsibilities:
- Serve as SME/technical lead for toxicology and biocompatibility for medical devices (including biosorbable/implantable materials).
- Evaluate biological safety of device products/materials per international regulations/standards, GLP, and internal procedures.
- Plan, execute, coordinate, and interpret in vitro/in vivo biocompatibility and toxicology studies.
- Apply ISO 10993 and regulatory requirements; solve biocompatibility problems.
- Coordinate biocompatibility test strategies; review, interpret, and summarize data; support risk assessment documentation.
- Provide technical guidance to cross-functional internal teams and external partners across the product lifecycle.
- Support audits and regulatory/notified body requests (e.g., TUV, BSI) and submissions/reviews.
- Identify/evaluate risks and drive resolution; participate in continuous improvement.
- Ensure compliance with health/safety/environment practices and relevant regulations.
Qualifications/Requirements:
- MS or Ph.D. in Toxicology (or related field).
- 6+ years in medical devices; 8–10 years in toxicology/biocompatibility assessments (medical device/pharma/consumer products); medical device experience strongly preferred.
- Experience in regulated medical device safety environment (submissions/audits; worldwide registration preferred).
- Experience with absorbable biomaterials for implantable devices (degradation, toxicokinetics) required.
- Knowledge of biocompatibility/toxicology assessments and ISO 13485/ISO 10993/ISO 14971 and design control systems.
- Laboratory animal care/use strongly preferred; manufacturing-process understanding strongly preferred.
Required/Preferred Skills:
- Cross-functional collaboration, conflict resolution, technical leadership/mentorship.
- Strong written/verbal communication; proactive analytical problem-solving; tenacity.
- Travel up to 10%.
Benefits (time off): Vacation 120 hrs/yr; Sick 40 hrs/yr (CO 48; WA 56); Holiday pay 13 days/yr; Work/Personal/Family time up to 40 hrs/yr; Parental leave 480 hrs; Bereavement 240 hrs immediate/40 hrs extended; Caregiver leave 80 hrs; Volunteer 32 hrs; Military Spouse time-off 80 hrs.
Responsibilities:
- Serve as SME/technical lead for toxicology and biocompatibility for medical devices (including biosorbable/implantable materials).
- Evaluate biological safety of device products/materials per international regulations/standards, GLP, and internal procedures.
- Plan, execute, coordinate, and interpret in vitro/in vivo biocompatibility and toxicology studies.
- Apply ISO 10993 and regulatory requirements; solve biocompatibility problems.
- Coordinate biocompatibility test strategies; review, interpret, and summarize data; support risk assessment documentation.
- Provide technical guidance to cross-functional internal teams and external partners across the product lifecycle.
- Support audits and regulatory/notified body requests (e.g., TUV, BSI) and submissions/reviews.
- Identify/evaluate risks and drive resolution; participate in continuous improvement.
- Ensure compliance with health/safety/environment practices and relevant regulations.
Qualifications/Requirements:
- MS or Ph.D. in Toxicology (or related field).
- 6+ years in medical devices; 8–10 years in toxicology/biocompatibility assessments (medical device/pharma/consumer products); medical device experience strongly preferred.
- Experience in regulated medical device safety environment (submissions/audits; worldwide registration preferred).
- Experience with absorbable biomaterials for implantable devices (degradation, toxicokinetics) required.
- Knowledge of biocompatibility/toxicology assessments and ISO 13485/ISO 10993/ISO 14971 and design control systems.
- Laboratory animal care/use strongly preferred; manufacturing-process understanding strongly preferred.
Required/Preferred Skills:
- Cross-functional collaboration, conflict resolution, technical leadership/mentorship.
- Strong written/verbal communication; proactive analytical problem-solving; tenacity.
- Travel up to 10%.
Benefits (time off): Vacation 120 hrs/yr; Sick 40 hrs/yr (CO 48; WA 56); Holiday pay 13 days/yr; Work/Personal/Family time up to 40 hrs/yr; Parental leave 480 hrs; Bereavement 240 hrs immediate/40 hrs extended; Caregiver leave 80 hrs; Volunteer 32 hrs; Military Spouse time-off 80 hrs.