Senior Occupational Toxicologist
AstraZeneca Göteborg / Apotekarjobb / Mölndal
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hela Sverige 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.
Global Safety, Health and Environment (SHE) exists to help AZ 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.
An exciting opportunity has arisen for a Senior Toxicologist to join our team!
As as Senior Occupational Toxicologist, you will be providing expertise for occupational and product quality-related toxicology within Global Safety, Health and Environment (GSHE) for AstraZeneca and the AstraZeneca Group.
You will contribute to the overall strategy that enables a harmonized and consistent approach for occupational toxicology and product quality disciplines across the entire product pipeline, including both biologically-derived and chemically synthesized bio/pharmaceuticals from development through commercialization.
If you have a background, as well as being able to demonstrate experience in some of the following areas; ecotoxicology, toxicology, environmental risk assessment, chemistry, and/or industrial hygiene we will make the most of your skills and passion by actively supporting you as we believe in the potential of our people and we will help you develop beyond what you thought possible.
Key responsabilities
• 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).
• Establish health-based exposure limits and author documentation for regulatory compliance, including Permitted Daily Exposures (PDEs) to support of product quality (e.g. cleaning validation and product excursions encountered in large and small bio/pharmaceutical manufacturing) and worker health and safety activities (e.g. HAZR&D, occupational exposure bands and limits (OEBs and OELs)).
• Provide toxicology support for nonclinical safety assessment (regulatory/project toxicology) groups with requests from project teams, development and toxicology leads, regarding the following types of risk assessments:
• Process related impurities, intermediates and degradants
• Non-process related impurities (i.e. raw materials)
• Extractables and leachables
• Excipients
• Quality excursions (i.e. contaminants, extraneous matter)
• Qualification for new and platform products
• Provide expert technical advice and prepare toxicology assessments in support of health hazard classification for Safety Data Sheets according to GHS and CLP, and Dangerous Goods to support worker safety as well as...FOR FULL JOB DESCRIPTION AND TO APPLY PLEASE VISIT ASTRAZENECA.COM.
Essential skills
• PhD in pharmacology, toxicology, biology 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.).
• Applied, working knowledge of the general principles, practices and procedures of multiple facets including pharmacology, toxicology, biology, and chemistry and the relationship between toxicological, physical, and chemical properties of small and/or large molecule pharmaceuticals and biologics.
• Effective problem and conflict resolution skills and proven team focus.
• Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills.
• Ability to influence strategically and persuade tactfully, to obtain desired outcomes while maintaining effective, positive, organizational relationships.
Desirable skills
• Professional Business Qualification/Certifications (e.g., DABT, ERT, CIH).
• Occupational Health and Industrial Hygiene 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)
• Familiarity with the latest research and thinking
• Willingness to travel both domestically and internationally.
• May be required to liaise with external topic experts and customers/suppliers.
• Flexibility in terms of locations where candidates can be based but with a preference for Sweden, UK or US.
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We're inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines - strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You'll be part of a team that's rolling back the frontiers of science to turn yesterday's impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients - and in return, we'll help you develop way beyond what you thought possible.
Publiceringsdatum2018-02-13Så ansöker duSista dag att ansöka är 2018-02-28
Klicka på denna länk för att göra din ansökanFöretagAstraZeneca Göteborg
AdressAstraZeneca Göteborg
Pepparedsleden 1
43183 MÖLNDAL
KontorsadressPEPPAREDSLEDEN 1
Jobbnummer 3960565
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