Process Development Senior Scientist
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Process Development Senior ScientistLive
What you will do
Lets do this. Lets change the world. In this dynamic role you will provide technical and project leadership while integrating information generated by functionally teams with varied strengths to ensure success through the commercialization process. Responsibilities include:
- Serving as a leader on Drug Product Teams responsible for planning, designing, executing, documenting laboratory studies related to drug product design, formulation, process development, tech transfer and regulatory authoring in support of commercialization and lifecycle management of Amgen's pipeline
- Managing a team of engineers and scientists to advance program and functional objectives
- Expanding utilization of advanced IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis
- Authoring and reviewing guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions
- Drive continuous improvement in drug product development process through technological innovation and application of first principles
- Serve as a subject matter expert in drug product technologies and help drive best practices and technical advancements
- Delivering progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs
- Working effectively in a highly matrixed team environment to influence and inspire change, efficiency, and cultivate positive relationships
- Ability 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 Process Development Science professional we seek is a collaborative partner with these qualifications.
- Doctorate degree & 2 years of scientific experience OR Masters degree & 5 years of scientific experience OR Bachelors degree & 7 years of scientific experience.
- Advanced degree in Engineering, Pharmaceutics, Biotechnology, Material Science or related subject area
- 5 years or more proven ability 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, so we work to care for our teammates professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
#Operations21Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your 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 a 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 an accommodation.
Join UsIf 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 cancer, 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.