Commercial Attribute Science - Scientist
Company: Amgen
Location: Somerville
Posted on: June 16, 2022
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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
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