Amgen

Process Development Scientist

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Jul 18, 2021
Ref
R-119041
Required Education
Bachelors Degree
Position Type
Contract

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.

Process Development Scientist

Live

What you will do

Lets do this. Lets change the world. In this dynamic role you will join us on our effort to deliver innovative human therapeutics to patients worldwide as an Attribute Sciences Team Lead (ASTL) responsible for analytical leadership of large molecule commercial programs. Job responsibilities include:

  • Contribute to global regulatory filings by authoring analytical CMC sections and RTQs ensuring success of commercial approval and launch
  • Analytical method lifecycle management including method transfers, improvements, remediations and validation
  • Provide analytical technical support to commercial testing and manufacturing operations
  • Troubleshooting and deviation management relating to product quality and method-related investigations including OOS/OOT root cause determinations
  • Interface and collaborate with other functional areas in matrix environment, including team across various geographic locations in different time zones
  • Preparation of clear written and verbal communications to key business partners and senior leadership
  • Manage activities at contract manufacturing and testing sites and reference standard qualification and associated activities.
Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is hard-working with these qualifications.

Basic Qualifications

  • Doctorate degree OR Masters degree and 4 years of experience OR Bachelors degree and 6 years of experience
Preferred Qualifications
  • Strong understanding of protein therapeutics analytical life cycle development and protein product quality attributes and analytical control strategy
  • Extensive experience in a wide variety of analytical techniques such as CEX, SEC, Reverse Phase Chromatography, HILIC, CE, Compendial methods (e.g. pH, Osmolality, Karl Fisher titration, etc.), Gels, Bioassays and Immunoassays
  • Ability to support investigations in an Analytical Subject Matter Authority (SMA) capacity
  • Knowledge of GMP requirements and familiarity with USP monographs and chapters, as well ICH guidance documents related to analytical method transfer and validation etc.
  • Effective communication skills and ability to provide cross-functional leadership for analytical project management
  • Excellent technical writing skills and attention to detail in authoring 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith 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.

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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.