Process Development Scientist: Drug Product Technologies (Synthetics)
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Process Development Scientist: Drug Product Technologies (Synthetics)Live
What you will do
Lets do this. Lets change the world. In this vital role you will join our Pivotal Synthetics Drug Product Technologies in the Thousand Oaks, CA headquarters. This group is responsible for late stage synthetics drug product formulation and process development, focusing on, but not limited to solid dosage form development.
- Participate in cross-functional Synthetics Drug Product Commercialization Teams responsible for conducting tablet/capsule/parenteral formulation and process development/characterization of pipeline products and for supporting commercial products through lifecycle management
- Design, plan, execute, and document formulation and process development studies
- Apply scientific/engineering principles and techniques to develop, characterize and implement processes and next generation technologies to solve technical challenges
- Apply statistical/data analytics techniques to draw conclusions and make informed decisions
- Participate in GMP manufacturing of clinical trial materials to support clinical studies as needed.
- Provide support to manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non-conformance investigations
- What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The dynamic professional we seek is hardworking with these qualifications.Basic Qualifications:
- Doctorate degree OR Masters degree and 4 years of scientific experience OR Bachelors degree and 6 years of scientific experience
- Advanced degree in Pharmaceutics, Chemistry, Chemical Engineering, Mechanical Engineering, Materials Science, Biotechnology or related subject area
- Experience in small molecule pharmaceutical development and manufacturing, formulation and process development, process characterization, technical transfers to manufacturing sites, and statistical design and analysis of experiments (DOE), and regulatory authoring.
- Experience in 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.).
- Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g. SQL), as well as data visualization tools (e.g. Tableau, Spotfire, D3js) and knowledge of at least one statistical software package (e.g. SAS, JMP or Minitab)
- Strong project management skills, including the ability to handle ones project resources (material, staffing, time, etc.)
- Good organizational skills with strong attention to detail
Some of the vast rewards of working here
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.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comEqual 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.