Company: Winc Australia
Posted on: April 3, 2021
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Bio-compatibility and Extractable/leachables of Class III medical
devices for Cerus. 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
- 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
- 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
- Identify and manage external sub-specialty SME in
- 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. Professional
- 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
- 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. Global Headquarters:
2550 Stanwell Drive Concord, CA USA 94520 +1 925.288.6000
Keywords: Winc Australia, Concord , Toxicology Director, Executive , Concord, California
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