Amgen Process Development Senior Scientist in Thousand Oaks, California
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. 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.
The Pivotal Drug Substance Technologies organization at Amgen develops, characterizes and supports the commercialization of the drug substance manufacturing processes for all late-stage programs across the Amgen portfolio, enabling advancement of programs from Ph II/III clinical trials to marketing application and commercial launch.
The Senior Scientist will manage an integrated group of cell culture and purification scientists working together to advance Amgen’s rich, exciting and dynamic pipeline located at our Thousand Oaks site, this scientific leadership position will be responsible for the development, characterization, scale-up and support of upstream and downstream drug substance processes to enable commercial advancement of programs from clinical trials to marketing application. The successful candidate will lead the group to apply platform approaches and utilize solid problem-solving skills to rapidly solve development challenges and build robust processes with efficient experimentation. As part of this leadership role, he/she will develop strong teams and support staff in their career development.
Working closely with Attribute Sciences, Drug Product Technologies and partners in the Operations network, this role will also require leadership of matrix cross-functional teams that deliver robust drug substance commercialization data packages (including authoring of CMC sections of regulatory documents, interaction with regulatory agencies, support of technology transfers and working with various contract development and manufacturing organizations). With Amgen’s biology first approach, the position provides the unique opportunity of being able to work on multiple modalities from antibodies and oncolytic viruses to bispecifics and siRNAs.
Additionally, the candidate will drive innovation and utilize out-of-the-box thinking to lead or support technology advancement efforts at Amgen. Expanding Amgen’s external eminence as well as representing Amgen in the external scientific community would be other expectations.
Doctorate degree and 2 years of scientific experience OR
Master’s degree and 6 years of scientific experience OR
Bachelor’s degree and 8 years scientific experience
Doctorate in Chemical Engineering, Biochemical Engineering, or other relevant sciences with 4+ years of experience
Proven track record problem solving and trouble-shooting in a process development environment; Demonstrated ability to independently identify, develop and implement scientific solutions to practical problems
Experience with drug substance commercialization activities, including interactions with regulatory agencies; Familiarity with design of experiments and statistical analysis of data
Strong expertise in purification and harvest technologies
Track record of innovation; Demonstrated eminence in the scientific community through a sustained record of peer reviewed publications
Motivated self starter with excellent interpersonal and organizational skills; Excellent verbal communication and scientific writing skills
Leadership experience of progressively increased scope and a demonstrated ability to inspire and lead a group of scientists to deliver on complex and challenging objectives in defined timelines
Demonstrated success working with diverse team members in a dynamic, cross-functional environment
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.
Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.