Amgen Process Development Senior Scientist in Thousand Oaks, California
Amgen is currently seeking a Process Development Senior Scientist for our Pivotal Drug Product Technologies Group in Thousand Oaks, CA. This group supports drug product formulation and fill/finish process development for Amgen’s Late-Stage biologics. The Senior Scientist will provide technical and project leadership while integrating information generated by functionally diverse teams to ensure success through the commercialization process.
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 standard methodologies 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 foster 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 vital attribute professional we seek will have these qualifications.
Doctorate degree & 2 years of scientific experience or
Master’s degree & 5 years of scientific experience or
Bachelor’s degree & 7 years of scientific experience
Advanced degree in Engineering, Pharmaceutics, Biotechnology, Material Science or related subject area
5+ years of 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
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
Apply now 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.
Equal 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.
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 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.