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Occupational Toxicologist

Company: FDBT - FUJIFILM Diosynth
Location: Morrisville
Posted on: November 19, 2021

Job Description:

Overview The Occupational Toxicologist provides expertise in health hazard identification and risk assessment (primarily occupational and product related toxicology) across Fujifilm Diosynth Biotechnologies--- global sites, ensuring safe laboratory and manufacturing work practices as well as product quality and safety. External US The Occupational Toxicologist provides expertise in health hazard identification and risk assessment (primarily occupational and product related toxicology) across Fujifilm Diosynth Biotechnologies--- global sites, ensuring safe laboratory and manufacturing work practices as well as product quality and safety.MAJOR ACTIVITIES AND RESPONSIBILITIES:

  • Provide robust, scientifically-sound risk health hazard assessments for employees handling proprietary and non-proprietary biomolecules used in the production of medicinal products in the workplace and environmental toxicology assessments.
  • Update and revise FDB procedures and guidelines related to health hazard assessment. Revise and/or develop hazard banding or default methodologies for early stage projects in lieu of established health-based exposure limits (HBELs).
  • Establish HBELs and author documentation for regulatory compliance, including Acceptable Daily Exposures (ADEs) to support product quality (e. g. cleaning validation, carryover limits, impurities) and worker health and safety activities (e. g. occupational exposure limits (OELs)).
  • Provide toxicological risk assessments and advice for project teams relating to
    • Impurities, intermediates and degradants
    • Extractables and leachables
    • Excipients
    • Impact of process excursions (i. e. contaminants, extraneous matter)
    • Provide expert technical advice and prepare toxicology assessments in support of health hazard classification:
      • Compiling and reviewing of Safety Data Sheets
      • Chemical notification/registration
      • Provide technical and scientific support for environmental impact assessments.
      • Collaborate with EHS, operations, Process Development and engineering groups as part of comprehensive occupational hazard evaluation, control and risk assessment.
      • Support FDB subject matter experts to complete Genetically Modified Organism risk assessmentsBACKGROUND REQUIREMENTS:
        • Degree in toxicology, pharmacology, industrial/occupational health or related biomedical science field.
        • Experience in hazard/risk assessment within pharmaceuticals and/or bio-pharmaceuticals industry.
        • Proven proficiency in technical science writing, specifically regarding risk assessments.
        • Experience in toxicology assessments for both occupational (e. g. worker exposure) and product quality (e. g., patient safety).
        • Fluency in relevant international regulations and guidelines for both worker and product safety (EMA, FDA, ICH, OSHA, COSH, etc.).
        • Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills.Desirable skills
          • PhD in pharmacology, toxicology, biology or related biomedical science field
          • Professional business qualification/certifications (e. g. Certified by American Board of Toxicologists or European Registered Toxicologist).
          • Industrial Hygiene and/or Occupational Health experience: occupational exposure assessment and controls, containment strategies and worker protection.
          • Operational expertise in risk management and contingency planning:
          • Working understanding of risk in terms of hazard (toxicology) and exposure/controls (industrial hygiene)FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 --- 130 and Export Administration Regulations in 15 C.F.R. Part 730 --- 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company---s ability to secure an export authorization.FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com.To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Keywords: FDBT - FUJIFILM Diosynth, Cary , Occupational Toxicologist, Other , Morrisville, North Carolina

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