Senior Scientist

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Job description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Live

What you will do

Lets do this! Lets change the world!

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, and

• ensuring patient and staff safety

In this role you will mature core toxicology programs to manage patient safety and EHSS risks of Amgen products, including those from drugs, manufacturing materials, primary containers, and drug-delivery device combination products, as they advance from development to commercialization, and post-approval. Primary role includes performing CMC/Quality toxicology assessments, and supporting Occupational toxicology. Responsibilities include:

• Prepare toxicological assessments 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 and/or manage toxicology assessments of process reagents and excipients used in Amgen drug development processes and formulations.

• Prepare product quality toxicology assessments to support non-conformances and product complaints.

• Conduct or assist with patient and/or worker safety risk assessments.

• Classify drug candidates into Occupational Exposure Bands (OEBs) for worker safety, and categorize hazards according to the Globally Harmonized Standard (GHS) for Safety Data Sheets (SDSs) and labeling to support worker safety.

• Derive Occupational Exposure Limits (OELs) for drug candidates and documented in product Hazard Assessment Monographs, to support worker safety.

• Monitor scientific developments 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.

• Coordinate Amgen EHSS contributions for influencing external scientific and regulatory activities and key initiatives such as ICH M7 (mutagenic impurities) and updates to EU GMPs (setting health-based limits for pharmaceuticals).

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of toxicology experience

Or

Masters degree and 6 years of toxicology experience

Or

Bachelors degree and 8 years of toxicology experience

Or

Associate's degree and 10 years of toxicology experience

Or

Highschool diploma / GED and 12 years of toxicology experience

Preferred Qualifications:

• MS or Ph.D. in toxicology, pharmacology, or related health sciences

• Toxicology board certification (DABT or ERT) and minimum 5 years of experience in the pharmaceutical/biotech industry

• Experience with the principles and practice of leachables/extractables studies, chemical characterization of packaging and device materials/components, and risk-based toxicology assessments of extractables and leachables

• Knowledgeable of the industry practice (e.g. PQRI, BPOG), as well as regulatory guidelines and standard (e.g. ICH, ISO) to support extractable/leachable assessments

• Research skills with literature searches, toxicology databases, regulatory databases and computational tools. (e.g., OECD Toolbox, Toxtree, Benchmark Dose (BMD))

• Expert knowledge with resourceful data interpretation for derivation of toxicology-based limits (e.g. Permissible Daily Exposure values) and application of thresholds of toxicological concern (ICH M7 TTC, Cramer TTC)

• Prepare toxicological risk assessment reports on product quality and safety

• Experience in hazard/risk assessment within pharmaceutical and/or biopharmaceutical industry

• Working knowledge of biocompatibility evaluations (ISO10993-1) for medical devices and drug-device combination products

• Good understanding of pharmaceutical development

• Strong scientific and technical writing skills and proficiency with EndNote or equivalent

• Proficient in Microsoft Office and other computer software systems

• Strong team building skills

• Process driven with a strong Operational Excellence attitude and project management skills

• Strong communication and presentation skills, action oriented, self-starting, program development and project management

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

#Operations21Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.