Cerus is seeking an accredited toxicologist to provide comprehensive toxicological support and leadership for Class III medical device, therapeutic and combination drug/device projects in the transfusion medicine space. This individual will interface with internal stakeholders (scientists, engineers, regulatory), external sub-specialists, CRO and regulatory authorities to provide broad support for programs from research stage through commercialization. Experience in biocompatibility and expertise in extractables and leachables are highly desired.
- Senior-level contributor responsible for proactively establishing toxicology strategy and providing oversight on execution for Class III medical device, therapeutics and combination drug/device programs. Communicate tox strategy to cross-functional project teams, ensuring alignment with business needs.
- Lead and/or manage the design, monitoring and interpretation of In Vitro and In Vivo non-clinical safety studies conducted under Good Laboratory Practices (GLP).
- Author/review SOPs, toxicology reports and regulatory summaries in collaboration with cross-functional teams, contract laboratories and suppliers.
- Identify and manage external laboratories to perform toxicological studies. Analyze and provide oversight for all tox studies such as biocompatibility testing: extractable and leachable, chemical characterization and biological impact evaluations.
- Identify and manage external sub-specialty SME in toxicology.
- Ensure compliance with global regulatory requirements and standards related to biological safety such as ISO 10993.
- Author regulatory submissions and responses to evaluations
- Represent Cerus professionally as required to effectively author and communicate toxicology information.
- Ph.D. in Toxicology, Biochemistry, Biomedical Engineering, Bioengineering, Biology with 10+ years’ experience or MS Degree with 7+ years’ experience in biocompatibility, toxicology, and/or process validation.
- DABT Certification needed.
- Fundamental understanding of global regulatory standards relevant to development of Class III medical devices, therapeutics and combination drug/device such as ISO 10993 standards.
- Demonstrated ability to critically review detailed scientific information and assess areas for improvement through a strong publication track record.
- Demonstrated ability to work well with diverse cross-functional teams in a highly matrixed organization.
- Track record of strong leadership and influencing skills
- Experience with biomaterials, toxicological assessments, E & L analysis for materials, container-closure systems, processes for medical device manufacturing, and biocompatibility assessment a strong plus.
Travel and location:
- This position is based in Concord, CA. However, consideration for remote work may be considered for very strong candidates.
- This position will require some domestic and international travel.