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Toxicology Director

Company: Winc Australia
Location: Concord
Posted on: April 3, 2021

Job Description:


At Cerus, we are proud of our consistent and unwavering focus to secure blood safety around the globe.
We operate as one team and resolve to attract and retain the best people in the business.
We operate in multiple cultures and geographies and work in a coordinated, mutually supportive fashion.
View our mission statement and core values

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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. Responsibilities:

  • 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. Professional Profile:
    • 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. 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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