Career CategoryScientific
Job DescriptionSenior Principal ScientistWhat you will doLet's do this. Let's 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 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).
- The role is hybrid, option for remote work may be available
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional individual we seek is an individual with these qualifications
Basic Qualifications:- Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 2 years of toxicology experience OR
- Master's degree and 5 years of toxicology experience OR
- Bachelor's degree and 7 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 leachable/extractables studies, chemical characterization of packaging and device materials/components, and risk-based toxicology assessments of extractables and leachable
- 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
- Proficiency in Microsoft Office and other computer software systems
- 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
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.comSalary Range168,392.65USD -227,825.35 USD
