Senior Principal Scientist

BioSpace; Thousand Oaks (CA); Hybrid; USD 150,000 - 210,000; Full time

Job summary

Amgen seeks an experienced toxicologist in the Product Stewardship group within EHSS to advance patient safety and manufacturing integrity. The role involves maturing core toxicology programs and risk-based assessments across development to post-approval.

The candidate will apply ISO10993, derive OELs, classify exposures, and support regulatory interfaces while contributing to a hybrid work model with potential remote options.

Qualifications

• PhD/MD/PharmD with toxicology experience or advanced degrees with relevant post-doc experience.
• Graduate degrees with clinical or industry toxicology exposure are preferred.

Responsibilities

• Mature core toxicology programs to manage patient safety and EHSS risks across development to post-approval.
• Prepare toxicology assessments of leachable/extractables, primary containers, and drug-device products.
• Support biocompatibility evaluations (ISO 10993-1) and leachable substances considerations for medical devices.
• Prepare and manage toxicology assessments of process reagents and excipients.
• Prepare product quality toxicology assessments to support non-conformances and product complaints.
• Conduct or assist with patient and worker safety risk assessments.
• Classify drug candidates into Occupational Exposure Bands (OEBs) and derive Occupational Exposure Limits (OELs).
• Monitor scientific developments and perform literature searches to inform regulatory compliance and safety.
• Coordinate EHSS contributions for external scientific and regulatory initiatives (ICH M7, EU GMPs).

Skills

Toxicology analysis

Regulatory compliance

Occupational exposure

Literature review

Toxicology writing

Education

PhD in Toxicology / Pharmacology / related

MD/PharmD with toxicology

MS in toxicology

BS in related field with toxicology experience

Tools

EndNote

Microsoft Office

OECD Toolbox

Toxtree

Benchmark Dose (BMD)

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Principal Scientist

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

Responsibilities

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 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
• Masters degree and 5 years of toxicology experience OR
• Bachelors 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 Us

As 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, well 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.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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 accommodation.