Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

Senior Principal Scientist

What you will do

Let'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

Additional Qualifications/Responsibilities

What we expect of you

We 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

Salary Range

168,392.65USD -227,825.35 USD