Career CategoryScientific
Job DescriptionScientific DirectorWhat you will doLet'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.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional individual we seek is a leader with these qualifications
Basic Qualifications:- 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
Preferred Qualifications:- 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.
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.comIn 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.
Salary Range211,407.75USD -286,022.25 USD
