Process Development Senior Associate
Job ID: R-116543
Location: Thousand Oaks, CA, US
Amgen is currently seeking an Analytical Research Associate in our Pivotal Attribute Sciences Department in Thousand Oaks, CA. This group is responsible for late phase analytical development, including method development, method validation, method transfer, process and product development support, and GMP testing of late phase drug substances and drug products.
The Research Associate will work closely with a team of analysts and scientists responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes in product and process for late phase synthetic programs.
•Collaborate closely with drug substance and drug product process development colleagues
• Monitors or follows established experimental design and protocols and performs routine tasks and studies to obtain reproducible and reliable results with limited supervision
• Skilled and/or knowledgeable in the use of standard laboratory equipment and with one or more major laboratory instruments/techniques
• Effectively trouble-shoots equipment and experimental difficulties
• Develops and implements new protocols with moderate review
• Participates in department-wide support efforts such as safety, recruiting and committees
• Degree in Biology, Biochemistry or Analytical Chemistry; experience in a Biopharmaceutical working environment
Master's degree or Master's degree
Bachelor's degree and 2 years scientific experience
•Experience in a wide variety of analytical techniques including mass spectrometry, UV, FTIR, chromatography, dissolution, etc.
•Knowledge of 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
•Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner
•Works well in cross-functional teams, and across various geographic locations in different time zones
We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.
A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.
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.