HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Process Development ScientistLive
What you will do
Lets do this. Lets change the world. In this vital role you 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. Responsibilities include:
- Integrate and successfully utilize platform and prior product knowledge to advance Amgen practices 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.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Scientific professional we seek is a collaborative partner with these qualifications.
- Doctorate degree or Doctorate degree completed in 2021 OR Masters degree and 4 years of scientific experience OR Bachelors degree and 6 years of scientific experience
- PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering
- Experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development is a plus.
- 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 analytical techniques including chromatography, mass spectrometry, UV, NMR, FTIR, solid state 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
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.comEqual Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Join UsIf 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.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.