AstraZeneca Pharmaceuticals LP Occupational Toxicologist in Cambridge, United Kingdom

Global Safety, Health and Environment (SHE) exists to help AstraZeneca protect our people and the planet. We drive improvement in SHE performance, maintain compliance and otherwise protect the company’s reputation. We do this by setting strategy and providing specific SHE expertise or accessing it through the wider SHE network.

We lead our industry in our development of a strong and varied pipeline. This means our people are here to win, we give you a breadth of opportunities to be curious and do cutting edge, unique work that has big impact on science and medicine.

Working on a strong pipeline means so much more than producing innovative, groundbreaking medicines. It allows AstraZeneca people to be part of long-term development programs with the variety that comes from working at the leading edge of science and technology.

As an Occupational Toxicologist or Health Hazard Assessment Specialist, you will be providing expertise for health hazard and risk assessment (primarily occupational and product quality-related toxicology) within Global Safety, Health and Environment (GSHE) for AstraZeneca and the AstraZeneca Group.

This is a temporary position for a worker going on parental leave. One year contract with possibility of extension.

Key responsibilities

  • Provide robust, scientifically-sound risk management processes to support health hazard assessment for: employees handling proprietary and non-proprietary chemicals used in the production of medicinal products in the workplace, environmental toxicology and product quality activities (primarily associated with manufacturing).

  • Update and revise AZ 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 Permitted Daily Exposures (PDEs) to support of product quality (e.g. cleaning validation, impurities and product excursions and worker health and safety activities (e.g. occupational exposure bands and limits (OEBs and OELs)).

  • Provide toxicological risk assessments for project teams and development and regulatory/project toxicology leads

  • Impurities, intermediates and degradants

  • Extractables and leachables

  • Excipients

  • Quality excursions (i.e. contaminants, extraneous matter)

  • Provide expert technical advice and prepare toxicology assessments in support of health hazard classification:

  • Safety Data Sheets according to GHS and CLP, and Dangerous Goods

  • Chemical notification/registration (i.e., EU REACH, China REACH, etc.)

  • Provide technical and scientific support for Environmental Reference Concentrations and Maximum Tolerable Concentrations.

  • Collaborate with industrial hygiene network, operations, R&D and engineering as part of comprehensive occupational hazard evaluation, controls and risk assessment.

Essential skills

  • Advanced 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 chemical monographs for risk assessment.

  • 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, ISO, USP, 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., DABT, ERT, CIH).

  • 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)

Salary for this role is competitive.

Location for this role will be Snäckviken/Södertälje, Gothenburg, Cambridge, UK or Gaithersburg, US.

If you are interested, apply now!

For further information regarding this role please contact Brad Stanard, brad.stanard@astrazeneca.com

We encourage you to send your application as soon as possible, since interviews will be held continuously, but no later than February 28th 2019.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.