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Sr Manager EHSS - Product Stewardship Toxicology

Thousand Oaks, CA

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Sr Manager EHSS - Product Stewardship Toxicology
Thousand Oaks
We are seeking an experienced toxicologist in the Product Stewardship group within our Environment, Health, Safety and Sustainability (EHSS) organization. This position has a broad reach and supports:
bringing new drugs to market
ensuring staff and patient safety, and
management of environmental risks
In this role you will mature core toxicology programs to manage EHSS risks of Amgen products as they advance through development. Role includes support of Quality toxicology, Occupational toxicology and Environmental toxicology. Responsibilities include:
Classify drug candidates into Occupational Exposure Bands pursuant to the Globally Harmonized Standard (GHS), as well as develop Occupational Exposure Limits
Conduct or assist with worker and/or patient safety risk assessments
Prepare product Hazard Assessment Monographs, Safety Data Sheets and Labeling to support worker safety
Prepare product quality toxicology assessments to support non-conformances and product complaints
Prepare and/or manage toxicology assessments of process reagents, excipients and process materials used in Amgen drug development processes
Prepare toxicological evaluations of leachables and extractables testing data as they relate to single use manufacturing, primary drug containers, delivery devices and drug-device combination products.
Support device organization with expertise on biocompatibility evaluations (ISO 10993-1) and more specifically on leachable substances (ISO 10993-17) for medical devices
Prepare Acceptable Daily Exposure (ADE)/Permitted Daily Exposure (PDE) monographs for product cross-contamination of manufacturing equipment pursuant to EMA Guidance and RiskMaPP.
Support environmental toxicology assessments and interpretation of data in preparation of environmental assessments as part of product marketing applications.
Monitor scientific development and conduct desktop research including literature searches, and critically evaluate and summarize scientific information and government regulations
Support scientific work including regulatory compliance, trade associations, and professional organizations relevant to work assignments,
Support REACH registration for EU, South Korea, Japan, and China.
Coordinate Amgen EHSS contributions for influencing external regulatory activities and key initiatives such as ICH M7 (mutagenic impurities) and updates to EU GMPs (setting health-based limits for pharmaceuticals)
Basic Qualifications:
Doctorate degree and 2 years of toxicology experience
Master's degree and 4 years of toxicology experience
Bachelor's degree and 6 years of toxicology experience
Associate's degree and 10 years of toxicology experience
High school diploma / GED and 12 years of toxicology experience
Preferred Qualifications:
Master's degree in toxicology and 15 years of experience in toxicology or PhD and 10 years of experience in toxicology
10 years of experience in the pharmaceutical/biotech industry
Experience in hazard/risk assessment within pharmaceutical and/or biopharmaceutical industry
Strong scientific and technical writing skills and proficiency with EndNote or equivalent
Proficient in Microsoft Office and other computer software systems
DABT certification
Knowledge of toxicology/risk assessment methodology such as benchmark dose, threshold of toxicological concern, cancer risk assessment, and dose-response assessment
Experience with toxicology assessments of leachables and extractables required of product contact materials and medical devices
Working knowledge of biocompatibility evaluations (ISO 10993-1) for medical devices and drug-device combination products
Understanding of environmental toxicology requirements for product marketing applications
Strong understanding of pharmaceutical development
Experience in monitoring GLP toxicology studies
Applied knowledge and understanding of toxicology principles and best practices, regulatory standards, and requirements in context of business activities
Strong team building skills
Process driven with a strong Operational Excellence mindset and project management skills.
Strong communication and presentation skills, action oriented, self-starting, program development and project management
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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