Pivotal Drug Product Senior Scientist
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Pivotal Drug Product Senior Scientist
What you will do
Let’s do this. Let’s change the world. In this vital role, you will work within the Pivotal Drug Product Technologies group, specifically providing technical expertise and leadership in support of high-throughput formulation and process development, business initiatives, and projects executed by diverse teams.
- Serve as a leader on late- stage portfolio advancement projects and also business initiatives related to drug product design, formulation, and process development, technology transfer, and regulatory authoring.
- Drive initiatives related to agile formulation development and the application of new technologies including high throughput and automation to enable speed to clinic and market.
- Expand utilization of advanced IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis.
- Support Quality and Regulatory interactions. Author and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions.
- Drive continuous improvement in the drug product development process through technological innovation and the application of first principles in process engineering.
- Deliver progress reports and presentations to ensure management awareness and engagement on the status, progress, and future program and functional needs.
- Work effectively in a highly matrixed team environment to influence and inspire change, efficiency, and foster positive relationships.
- Required to travel domestically and internationally up to 10% of the time.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The expert professional we seek is a strong contributor with these qualifications.
- Bachelor’s degree and 7 years of Scientific experience OR
- Master’s degree and 5 years of Scientific experience OR
- Doctorate degree and 2 years of Scientific experience
- Advanced degree in Engineering, Pharmaceutics, Biotechnology, Material Science or related subject area.
- 5+ years of biopharmaceutical experience that includes elements of formulation and fill/finish process development, process characterization, technical transfers to manufacturing sites, and statistical design and analysis of experiments, and regulatory authoring.
- Technical leader with demonstrated results driving programs forward.
- Experience in drug product regulatory strategy, RTQs, and agency engagement.
- Knowledge of, and hands-on experience with, bringing new biotech products to market, across various dosage forms and device delivery systems.
- Experience participating and leading global multi-functional teams.
- Outstanding knowledge of formulation, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling, and the associated GMP/Device documentation and regulatory filings.
- Strong problem solving and effective multi-functional interpersonal skills.
- Willing and able to learn new technologies at a rapid pace.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
The annual base salary range for this opportunity in the U.S. is $136,337 – $160,613.
In addition to the base salary, Amgen offers a Total Rewards Plan 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 including:
- 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 and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancers, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, or disability status.
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.
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