Senior Principal Scientist

About the role

Join Amgen’s 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 while ensuring patient and staff safety. You will mature core toxicology programs to manage patient safety and EHSS risks of Amgen products, including drugs, manufacturing materials, primary containers, and drug-delivery device combination products as they advance from development to commercialization and post-approval. The 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 the device organization with expertise on biocompatibility evaluations (ISO 10993-1) and 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.
• Derive Occupational Exposure Limits (OELs) for drug candidates and document them in product Hazard Assessment Monographs to support worker safety.
• Monitor scientific developments and conduct desktop research, including literature searches, critically evaluating and summarizing 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).

Requirements

• Doctorate degree (PhD, PharmD, or MD) with 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.

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 leachables.
• Knowledgeable of industry practice (e.g., PQRI, BPOG) and regulatory guidelines and standards (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 in 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).
• Experience preparing toxicological risk assessment reports on product quality and safety.
• Experience in hazard/risk assessment within the pharmaceutical and/or biopharmaceutical industry.
• Working knowledge of biocompatibility evaluations (ISO 10993-1) 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, with program development and project management experience.

Benefits

Amgen offers a Total Rewards Plan, based on eligibility, comprising 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.

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted on the careers site. Actual salary will vary based on several factors including but not limited to relevant skills, experience, and qualifications.

Schedule

The role is hybrid; an option for remote work may be available.