Commercial Attribute Science - Scientist

Company: Amgen
Location: Somerville
Posted on: June 16, 2022

Job Description:

Career CategoryOperationsJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.Commercial Attribute Science - ScientistLiveWhat you will doLet's do this! Let's 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 effectively apply 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.WinWhat we expect of youWe 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:Doctorate degreeOrMaster's degree and 4 years of scientific experience in analytical sciencesOrBachelor's degree and 6 years of scientific experience in analytical sciencesPreferred Qualifications:PhD in Analytical Chemistry, Materials Science2+ year's post-PhD experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method developmentStrong understanding of small molecule analysisExperience in a wide variety of analytical techniques, including mass spectrometry, UV, NMR, FTIR, chromatography, particle size determination, crystal characterization, etc.Experience developing and implementing methods for in-process testing, release and stability testingExperience in analytical testing requirements for immediate release and controlled release oral solid dosage drug productsFamiliarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.Proven understanding of GLP and GMP requirements and their application in a phase appropriate mannerExperience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage results against timelinesStrong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. advising and defending the Quality Target Product ProfileWorks well in cross-functional teams, and across various geographic locations in different time zonesExcellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documentsThriveSome of the vast rewards of working hereAs we work to develop treatments that take care of others, we also 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 journeyA diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on GlassdoorApply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.com.SummaryLocation: US - Massachusetts - CambridgeType: Full time

Keywords: Amgen, Somerville , Commercial Attribute Science - Scientist, Other , Somerville, Massachusetts