Scientific Director

Amgen • Thousand Oaks, CA

2d • $211,408 - $286,022 • Hybrid

About The Position

Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Scientific Director
What you will do
Let’s do this. Let’s change the world! In this vital role, as a Scientific Director, Product Stewardship Toxicology, you will provide scientific and strategic leadership for Product Stewardship within the Environment, Health, Safety & Sustainability (EHSS) organization. You will lead a highly specialized toxicology function supporting development, commercialization and lifecycle management of Amgen products while ensuring patient safety, worker safety and regulatory compliance across our global operations.
This is a highly visible leadership position requiring deep expertise in pharmaceutical toxicology, occupational toxicology, product quality toxicology and extractables and leachable risk assessment.
As the Scientific Director and functional leader for Product Stewardship Toxicology, you will provide strategic scientific direction while building and continuously improving toxicology programs that support Amgen's product portfolio from early development through commercialization and post-market lifecycle management. The role is hybrid, option for remote work may be available.
Key responsibilities include:
Strategic Leadership
Lead the Product Stewardship Toxicology function within EHSS.
Develop and mature toxicology strategies supporting global product development and commercialization.
Provide scientific leadership across Product Development, Process Development, Quality, Manufacturing, Medical Device Engineering, Regulatory Affairs and EHSS.
Influence enterprise decisions through expert toxicological risk assessment and strategic consultation.
Build organizational capability and continuously improve toxicology processes, standards and governance.
Product Quality & CMC Toxicology
Lead toxicological assessments supporting:
Extractables and Leachable (E&L)
Single-use manufacturing systems
Primary packaging
Container closure systems
Drug delivery devices
Combination products
Provide toxicology support for product quality investigations, non-conformances and product complaints.
Develop scientifically robust toxicological risk assessments supporting regulatory submissions and quality decisions.
Evaluate process-related impurities, reagents, excipients and manufacturing materials throughout product development.
Occupational Toxicology Leadership
Lead Amgen's occupational toxicology strategy supporting safe manufacture and handling of pharmaceutical compounds.
Perform and oversee Occupational Exposure Band (OEB) classifications.
Derive Occupational Exposure Limits (OELs) using current scientific methodologies.
Author and approve Hazard Assessment Monographs.
Conduct worker health risk assessments for development compounds, commercial products and manufacturing operations.
Support industrial hygiene programs through scientific interpretation of toxicological data.
Provide GHS hazard classifications supporting Safety Data Sheets (SDSs), labeling and global hazard communication.
Medical Device & Combination Product Support
Provide toxicology expertise supporting ISO 10993 biological evaluations.
Lead toxicological assessments under ISO 10993-17.
Partner with device engineering teams to support global medical device submissions.
External Scientific Leadership
Monitor emerging science, regulatory expectations and industry best practices.
Representing Amgen in external scientific organizations, professional societies and industry working groups.
Influence industry standards and regulatory initiatives including:
ICH M7, PQRI, BPOG, ISO, EU GMP, Occupational toxicology guidance
Program Leadership
Lead complex cross-functional projects involving multiple business partners.
Mentor and develop scientific talent.
Drive operational excellence, continuous improvement and knowledge management across the Product Stewardship function.

Requirements

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 5 years of directly related experience OR
• Master’s degree and 8 years of directly related experience OR
• Bachelor’s degree and 10 years of directly related experience

Nice To Haves

• PhD or MS in Toxicology, Pharmacology or another relevant life science discipline.
• Diplomate of the American Board of Toxicology (DABT), European Registered Toxicologist (ERT), or equivalent professional certification strongly preferred.
• Significant experience within the pharmaceutical or biotechnology industry.
• Demonstrated expertise in occupational toxicology, including derivation of Occupational Exposure Limits (OELs) and Occupational Exposure Bands (OEBs).
• Experience performing toxicological risk assessments supporting pharmaceutical manufacturing and worker safety.
• Extensive knowledge of extractables and leachable science, chemical characterization and toxicological evaluation.
• Strong understanding of pharmaceutical development, CMC and product quality risk assessment.
• Experience supporting medical devices and combination products under ISO 10993.
• Deep knowledge of regulatory expectations including ICH, ISO, PQRI, BPOG and applicable global regulations.
• Expertise applying toxicological thresholds including: PDEs, TTC, ICH M7, Cramer TTC.
• Experience using toxicology databases and computational toxicology tools including OECD Toolbox, Toxtree and Benchmark Dose software.
• Excellent scientific writing, technical communication and presentation skills.
• Demonstrated ability to influence senior stakeholders across multiple functions.
• Experience leading complex scientific programs and driving organizational change.
• Strong project management and operational excellence capabilities.

Responsibilities

• Lead the Product Stewardship Toxicology function within EHSS.
• Develop and mature toxicology strategies supporting global product development and commercialization.
• Provide scientific leadership across Product Development, Process Development, Quality, Manufacturing, Medical Device Engineering, Regulatory Affairs and EHSS.
• Influence enterprise decisions through expert toxicological risk assessment and strategic consultation.
• Build organizational capability and continuously improve toxicology processes, standards and governance.
• Lead toxicological assessments supporting Extractables and Leachable (E&L), Single-use manufacturing systems, Primary packaging, Container closure systems, Drug delivery devices, and Combination products.
• Provide toxicology support for product quality investigations, non-conformances and product complaints.
• Develop scientifically robust toxicological risk assessments supporting regulatory submissions and quality decisions.
• Evaluate process-related impurities, reagents, excipients and manufacturing materials throughout product development.
• Lead Amgen's occupational toxicology strategy supporting safe manufacture and handling of pharmaceutical compounds.
• Perform and oversee Occupational Exposure Band (OEB) classifications.
• Derive Occupational Exposure Limits (OELs) using current scientific methodologies.
• Author and approve Hazard Assessment Monographs.
• Conduct worker health risk assessments for development compounds, commercial products and manufacturing operations.
• Support industrial hygiene programs through scientific interpretation of toxicological data.
• Provide GHS hazard classifications supporting Safety Data Sheets (SDSs), labeling and global hazard communication.
• Provide toxicology expertise supporting ISO 10993 biological evaluations.
• Lead toxicological assessments under ISO 10993-17.
• Partner with device engineering teams to support global medical device submissions.
• Monitor emerging science, regulatory expectations and industry best practices.
• Representing Amgen in external scientific organizations, professional societies and industry working groups.
• Influence industry standards and regulatory initiatives including: ICH M7, PQRI, BPOG, ISO, EU GMP, Occupational toxicology guidance.
• Lead complex cross-functional projects involving multiple business partners.
• Mentor and develop scientific talent.
• Drive operational excellence, continuous improvement and knowledge management across the Product Stewardship function.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior