Process Development Principal Scientist: Drug Product Technologies (Synthetics)
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 Principal Scientist: Drug Product Technologies (Synthetics)Live
What you will do
Lets do this. Lets change the world. In this important role you will be part of our Pivotal Synthetics Drug Product Technologies Group in Thousand Oaks, CA. This group is responsible for late stage synthetics drug product formulation and process development, focusing, but not limited to solid dosage form development. The Principal Scientist will provide technical and project leadership while integrating information generated by cross functional teams to ensure success through the commercialization process.Responsibilities include:
- Lead cross-functional Synthetics Drug Product Commercialization Teams responsible for tablet/capsule/parenteral formulation development, process development/characterization, technology transfer, and regulatory authoring for pipeline and lifecycle management projects.
- Lead all aspects of and engage in the planning, design, execution, and documentation of formulation and process development studies.
- Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
- Serve as subject matter authority in drug product technologies and help drive standard methodologies and technical advancements
- Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs.
- Participate and lead global cross-functional teams working effectively in a highly matrixed team environment to inspire change, efficiency, and positive relationships
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The biotech science professional we seek is collaborative with these qualifications.
- Doctorate degree & 3 years of scientific experience OR Masters degree & 6 years of scientific experience OR Bachelors degree & 8 years of scientific experience
- Advanced degree in Pharmaceutics, Chemistry, Chemical Engineering, Biotechnology, Material Science, Material Engineering or related subject area
- 5 or more years of experience that includes elements of small molecule formulation and process development, process characterization, technical transfers to manufacturing sites, and statistical design and analysis of experiments (DOE), and regulatory authoring.
- Outstanding knowledge of typical unit operations for the manufacture of oral solid dosage forms (i.e. granulation, drying, milling, blending, compression, etc.), and the associated GMP documentation and regulatory filings.
- Experience with unique technologies (e.g., spray drying, hot melt extrusion, Wurster coating, etc.).
- Leadership of highly technical specialists with proven results driving forward pipeline and lifecycle management programs
- Experience participating and leading global cross-functional teams
- Strong problem solving and effective cross-functional communication skills.
- Ability to learn and act on dynamic information 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.