Process Development Sr Associate
- Employer
- Amgen
- Location
- Thousand Oaks, CA, US
- Start date
- Nov 6, 2019
View more
- Discipline
- Engineering, Manufacturing & Production, Process
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
The focus of this position is on analytical testing and analytical method development to advance Amgen's portfolio. The successful candidate will work cross-functionally and across sites while using analytical science to help drive efficient development and scalable understanding of processes and products in Amgen's pipeline.
Key Responsibilities:
Perform testing in both non-GMP and GMP environments for drug substance and drug product process development and for release of clinical material
Perform instrument maintenance and basic trouble shooting
Develop skills and knowledge to perform method development, validation, troubleshooting and transfer in the Pre-Pivotal environment for both drug substance and drug product
Maintain good understanding of cGMP principles and follow compliance requirements for GMP activities.
Timely notebook keeping; authoring reports, methods, presentations, and other technical documents for record keeping and facilitation of decision making
Practice good time management and prioritization when necessary
Work in team, practice good laboratory housekeeping and ensure safety
Basic Qualifications:
Master's degree
OR
Bachelor's degree and 2 years of relevant scientific or industry experience
Preferred Qualifications:
Master's degree and 2+ years of experience in Chemistry, Biochemistry, Pharmaceutical, Biotech, Life Sciences or Chemical Engineering industry
Background in analytical method development, organic chemistry, physical chemistry, and formulation development.
Understanding and hands-on experience with chromatographic techniques, such as liquid chromatography and gas chromatography, as applied to pharmaceutical development.
Understanding and hands-on experience with dissolution techniques for solid oral dosage forms.
Experiences in analytical technologies, such as mass spectrometry (MS), UV, FTIR and titrations
Experience to work with automation, data processing and data management systems related to analytical techniques
Familiar with cGMP regulations and practices.
Excellent written and oral communication skills
Demonstrated abilities in problem solving and multi-tasking
Ability to quickly adapt to a dynamic and fast-paced work environment.
Self-motivation for learning and growth
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
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert