Process Development 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 SCIENTISTLive
What you will do
Lets do this. Lets change the world. In this vital Scientist - Analytical Chemist role you will join our Commercial Attribute Sciences team.
Our Commercial Attribute Sciences department is responsible for commercial analytical support, including method validation, method transfer, method remediation, method investigation support, process and product development manufacturing support.
The Scientist will work closely with a team of analytical chemists, organic chemists and formulators responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes for synthetic manufacturing processes and synthetic products. The Scientist will integrate and successfully utilize platform and prior product knowledge to advance Amgen practices and ensure success of the commercial synthetic portfolio.Key Responsibilities:
- Define analytical control strategies and implement methodologies for commercial programs.
- Collaborate closely with drug substance and drug product process development colleagues.
- Facilitate activities at contract manufacturing and testing sites.
- May lead and develop a small group of scientists.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a collaborative and motivated team-player with these qualifications.Basic Qualifications:
Masters degree and 4 years of scientific experience
Bachelors degree and 6 years of scientific experiencePreferred Qualifications:
- PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering (earned on or before May 2021)
- 2+ years post-PhD experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development.
- Strong understanding of small molecule analysis, structure elucidation and solid-state characterization guided and informed by knowledge of organic chemistry.
- Experience in a wide variety of structure elucidation and physicochemical techniques.
- including mass spectrometry, UV, NMR, FTIR, chromatography, particle size determination, crystal characterization, etc.
- Developing and implementing methods for in-process testing, release and stability testing.
- Experience in analytical testing requirements for immediate release and controlled release oral solid dosage drug products.
- Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
- Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner
- Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines
- Solid communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
- Works well in cross-functional teams, and across various geographic locations in different time zones
- Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents
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.
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.