Process Development Principal Scientist
Amgen is seeking a Process Development Principal Scientist based either in Thousand Oaks, CA or Cambridge, MA. This leadership position is within the Process Development Pivotal Drug Substance Technologies group and reports to the Process Development Scientific Director.
The Principal Scientist will lead an integrated group of cell-culture and purification scientists working in combined teams to advance Amgen's dynamic pipeline. With Amgen's biology-first approach, the position provides a unique opportunity to work on multiple modalities, from antibodies and oncolytic viruses to bi-specifics and immuno-therapies. The Principal Scientist will apply established platform approaches to rapidly solve cell-culture challenges and design robust processes with efficient experimentation. Additionally, the Incumbent will drive new approaches and utilize out-of-the-box thinking to contribute to technology development. Finally, the Principal Scientist will demonstrate the desire to expand and develop skills in harvest and purification, thereby contributing to the integrated bioprocess development approach.
As part of this leadership role, he/she will develop strong teams and support staff in career development. The role will also provide leadership of cross-functional teams that deliver commercialization packages for drug substance manufacturing processes. The scope of work and responsibility span commercial process development, process characterization, support of technology transfer, authoring regulatory CMC documents, and interacting with regulatory agencies and working with various contract manufacturing organizations, driving innovation and expanding Amgen's external eminence and continuing to represent Amgen in the external scientific community. In addition, the position will lead and support efforts to develop and implement new technologies and new business strategies to drive organizational efficiency.
The Pivotal Drug Substance Technologies organization 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 the marketing application and commercial launch.
Doctorate degree and 2 years of Process Development and/or scientific experience
Master's degree and 6 years of Process Development and/or scientific experience
Bachelor's degree and 8 years of Process Development and/or scientific experience
Associate's degree and 10 years of Process Development and/or scientific experience
High school diploma / GED and 12 years of Process Development and/or scientific experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- 8 years of experience with a Doctorate / Masters in biological science discipline or bio/chemical engineering
- Expertise and experience in mammalian cell culture and cell sciences
- Experience with media development
- Experience in CMC commercialization process
- Leadership of a lab group or leadership experience of functional or cross-functional project teams
- Demonstrated results from leadership opportunities
- Track record of innovation and implementation of new technologies
- Experience in authoring BLA sections and interaction with regulatory agencies
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. 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.