Amgen

Process Development Scientist Attribute Science/Biologics

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Feb 23, 2021
Ref
R-112657
Required Education
Bachelors Degree
Position Type
Full time
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.

Process Development Scientist Attribute Science/Biologics

Live

What you will do

Let's do this. Let's change the world. In this vital role you will contribute to Amgen's diverse process development portfolio of therapeutic modalities with a focus on understanding process and product properties of large molecule drug candidates and assessing the quality attributes of protein therapeutics being developed across multiple therapeutic areas in Amgen's pipeline. Collaborate cross-functionally to drive the efficient transfer of technologies and to ensure appropriate delivery of procedures and processes.
  • Responsible for analytical leadership of pre-pivotal programs, Scientific and technical expertise to advance the pre-pivotal portfolio
  • Lead development and implementation of sophisticated analytical techniques both internally and through external collaborations.
  • Routinely craft experiments that lead to a fundamental understanding of a therapeutic protein's attributes and stability characteristics as a function of process development.
  • Investigates method performance, reliability, and improvement issues, and evaluates proposed changes to compendial or in-house methods.
  • Understanding of attributes criticality, stability and control strategy:
  • Deep understanding of product quality attributes and methodology to measure attributes.
  • Justification of specification and control strategy (setting acceptance criteria) and stability and expiry setting
  • Optimally functions as an Attribute Sciences representative on project teams. Responsibilities may include supervision and development of junior scientific staff members.
  • Excellent teamwork and experience working in cross functional teams
  • Excellent presentation skills and verbal and written communication skills
  • Support drug substance and drug product process development and protein characterization, collects analytical data to be used for regulatory submissions, and participates in technology transfer activities to contract and/or manufacturing sites (internal and external).
  • Authoring regulatory documents
  • Understanding of regulatory expectations for analytical methods, control and stability strategy and comparability.
  • Partner engagement
  • Excellent ability to network across functions and establish partnership and relationship building with partner organization (quality, regulatory CMC and supply chain)


Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master's degree and 4 years of directly related life science experience

OR

Bachelor's degree and 6 years of directly related life science experience

Preferred Qualifications:
  • Ph.D. in biochemistry, chemistry, chemical engineering or other life science area plus 4 or more years of industrial experience.
  • Proficient in method development using LC, CE or MS technologies.
  • Familiarity with protein characterization techniques.
  • Excellent verbal and written communication skills
  • Excellent team work and experience working in cross functional teams
  • Ability to manage priorities and adjust schedule to accommodate changes. Experience authoring scientific protocols and technical reports.
  • Prior experience authoring or contributing to regulatory filings.
  • Independent, accountable, attention to detail, ability to optimally balance multiple projects, and good interpersonal/communication skills are required.
  • Experience with MS Office suite of software (i.e., Word, PowerPoint, Excel) and collaborative tools (e.g., MS Teams, WebEx, Skype), computer-based applications such as CDOCS, EPIC, Electronic Lab Notebook, EDM Teams, etc.


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.