Senior Manager EHSS - Product Stewardship Toxicology
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.
Sr Manager EHSS - Product Stewardship Toxicology
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 run 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:
Prepare toxicological assessments of leachable 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).
What we expect of you
We are all different, yet we all use our unique contributions to serve patients.
The professional we seek will have these qualifications.
Doctorate degree and 2 years of toxicology experience
Masters degree and 4 years of toxicology experience
Bachelors degree and 6 years of toxicology experiencePreferred Qualifications:
MS or Ph.D. in toxicology, pharmacology, or related health sciences
Toxicology board certification (DABT or ERT) and demonstrated ability in the pharmaceutical/biotech industry
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
Prepare toxicological risk assessment reports on product quality and safety
Good understanding of pharmaceutical development
Strong scientific and technical writing skills and proficiency with EndNote or equivalent
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
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
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 UsIf 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.