Process Development Scientist Attribute Science/Biologics
- Employer
- Amgen
- Location
- Thousand Oaks, CA, US
- Start date
- Feb 25, 2021
View more
- Discipline
- Engineering, Process Engineer, Manufacturing & Production, Process, Science/R&D
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
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.
- 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.
Deep understanding of product quality attributes and methodology to measure attributes, stability and control strategy.
- Justification of specification and control strategy (setting acceptance criteria) and stability and expiry setting
Optimally functions as an Attribute Sciences representative on project teams.
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.
Authoring regulatory documents. Understanding of regulatory expectations for analytical methods, control and stability strategy and comparability.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The self-starter professional we seek is a scientist 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.
- 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.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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