JOIN AMGEN’S MISSION OF SERVING PATIENTS

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Process Development Senior Scientist – Pivotal Attribute Sciences

BASIC QUALIFICATIONS:

• Bachelor’s degree and 5 years of Scientific experience; Or
• Master’s degree and 3 years of Scientific experience; Or
• Doctorate degree PhD OR PharmD OR MD

PREFERRED QUALIFICATIONS:

• 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 development and drug substance, 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.
• Strong experience in liquid chromatographic and mass spectroscopic analysis.
• Experience in a wide variety of structure elucidation and physicochemical techniques including MS, NMR, UV, FTIR etc. Developing and implementing methods for in-process testing, release and stability testing.
• 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

Let’s do this. Let’s change the world. In this vital role you will be joining our Pivotal Attribute Sciences Department in Cambridge, MA. This group is responsible for late phase analytical development, including method development, method validation, method transfer, process and product development support, and GMP testing of late phase drug substances and drug products.

The Scientist will work closely with a team of analytical chemists, organic chemists, and formulation scientists responsible for the technical aspects of developing the analytical tools to gain understanding of key quality attributes in product and process for late phase synthetic programs. The Scientist will integrate and successfully utilize platform and in-depth product attribute knowledge to advance Amgen products and ensure success through pivotal clinical phases to marketing authorization application.

• Define analytical control strategies and implement methodologies for development of pivotal phase clinical programs.
• Develop, optimize, and authorize analytical methods for synthetic molecules release testing and characterization
• Collaborate closely with drug substance and drug product process development colleagues to achieve project objectives
• Provide analytical data to support drug substance and drug product development, including purity analysis, chiral purity and structure elucidation using mass spectrometry
• Manage activities at contract manufacturing and testing sites.
• May lead method transfer to CMO or contract testing labs
• Review and approve protocols, reports from CMO and contract testing labs
• Support project team lead to author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents.
• May lead and develop a small group of scientists.