Analytical Scientist- Pivotal Attribute Sciences, Thousand Oaks, California

Amgen

Job ID: R-110595
Location: Thousand Oaks, CA, US

HOW 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.

Analytical Scientist - Pivotal Attribute Sciences

Live

What you will do

Let's do this. Let's change the world. In this vital role you will join the Pivotal Attribute Sciences Department in Thousand Oaks, CA. 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 drug substances and drug products. 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 successfully utilize platform and prior product knowledge to advance Amgen practices and ensure success from FIH study through to marketing application.

Key Responsibilities:

• 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.
  
• Lead activities at contract manufacturing and testing sites.
  

Win

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 individual with these qualifications.

Basic Qualifications:

Doctorate degree or Doctorate degree completed by February 2021

OR

Master's degree and 4 years of scientific experience

OR

Bachelor's degree and 6 years of scientific experience

Preferred Qualifications:

• 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.
  
• 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 structure elucidation and physicochemical techniques including chromatography, mass spectrometry, UV, NMR, FTIR, chromatography, particle size determination, crystal 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.
  
• Strong 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
  

Thrive

Some of the vast rewards of working here

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.

• 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 Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
  

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Equal 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 Us

If 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.



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