Process Development Scientist
Job ID: R-103653
Location: Cambridge, MA, US 02139
Amgen is currently seeking a Scientist - Analytical Chemist in our Pivotal Attribute Sciences Department in Cambridge, MA. This group is responsible for pivotal phase analytical development, including method development, method validation, method transfer, process and product development support, and GMP testing of early phase drug substances and drug products. 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 products and ensure success from FIH study through to marketing application.
•Define analytical control strategies and implement methodologies for development of pivotal phase clinical programs.
•Collaborate closely with drug substance and drug product process development colleagues.
•Manage activities at contract manufacturing and testing sites.
•May lead and develop a small group of scientists.
Doctorate degree or Doctorate degree completed by October 2020
Master's degree and 4 years of scientific experience
Bachelor's degree and 6 years of scientific experience
•PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering
•2+ year's 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
•Strong 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
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.