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Associate Scientist

Company: Amgen
Location: Newbury Park
Posted on: November 22, 2021

Job Description:

HOW MIGHT YOU DEFY IMAGINATION?Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.Associate ScientistAmgen is currently seeking a Associate Scientist - Analytical Chemist in our Pivotal Attribute Sciences Department. This group is responsible for pivotal phase analytical development, including method development, method validation, method transfer, process and product development support, and GMP testing of early phase biologic drug substances and drug products. The Associate Scientist will work closely with a team of analytical chemists and formulators responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes for biologics manufacturing processes and biologic drug products. The Associate Scientist will integrate and successfully utilize platform and prior product knowledge to advance Amgen practices and ensure success from FIH study through to marketing application.LiveWhat you will doLets do this. Lets change the world. In this vital role you will be the liaison to our customers by providing clinical knowledge of our products to medical professionals.Amgen's medicines treat serious illnesses and our research address diseases with a limited number of treatment options. With a robust and differentiated pipeline, Amgen remains committed to advancing science to dramatically improve people's lives.Key Responsibilities:

  • Define analytical control strategies and implement methodologies for development of pivotal phase clinical programs.
  • Lead separation science and chromatography characterization of drug substance and drug products at various stages of development.
  • Collaborate closely with drug substance and drug product process development colleagues.WinWhat we expect of youBasic Qualifications:Masters degree and 2 years of Scientific experienceORBachelors degree and 4 years of Scientific experiencePreferred Qualifications:
    • BS in Analytical Chemistry, Biochemistry with emphasis or strong hands on experience in chromatography.
    • Experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development is a plus.
    • Experience in a wide variety of analytical techniques including liquid chromatography, UV, SEC, cIEF 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.
    • 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.ThriveSome of the vast rewards of working hereAs 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.
      • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
      • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
      • Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith 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.comAmgen 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 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 accommodation.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.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.

Keywords: Amgen, Los Angeles , Associate Scientist, Other , Newbury Park, California

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