Amgen currently has a vacancy for those looking to work as a Amgen Job Openings – Commercial Attribute Science for Full Time at their offices in Cambridge, MA. Applicants should be sure to read the job outline attentively if they intend to apply.
|Job Title:||Amgen Job Openings – Commercial Attribute Science||Company Name:||Amgen||Job Location:||Cambridge, MA||Job Type:||Full Time||Job Category:||Amgen||Job Link Expiry:||2023-12-30||Posted on:||Jobinton.com|
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.
- May lead and develop a small group of scientists.
- Collaborate closely with drug substance and drug product process development colleagues.
- Define analytical control strategies and implement methodologies for commercial programs.
- Facilitate activities at contract manufacturing and testing sites.
- Experience in a wide variety of analytical techniques, including mass spectrometry, UV, NMR, FTIR, chromatography, particle size determination, crystal characterization, etc.
- Strong 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 Profile
- Proven understanding of GLP and GMP requirements and their application in a phase appropriate manner
- Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
- Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage results against timelines
- Strong understanding of small molecule analysis
- Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents
- 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
- Experience in analytical testing requirements for immediate release and controlled release oral solid dosage drug products
- PhD in Analytical Chemistry, Materials Science
- Works well in cross-functional teams, and across various geographic locations in different time zones
- Experience developing and implementing methods for in-process testing, release and stability testing
Vacancy Type: Full Time
Job Location: Cambridge, MA
Application Deadline: N/A