The Amgen Thousand Oaks Cellular Sciences department is seeking an enthusiastic, highly motivated, and team-oriented scientist for the position of Process Development Senior Scientist, to join and lead our Biosafety Development group. The Senior Scientist will provide scientific, technical and managerial leadership in support of Biosafety Developments key responsibilities which include:
- Ensuring Viral Safety of biotechnology derived therapeutics by performing Viral Clearance Assessments for clinical and commercial programs
- Technology development to further and streamline Viral Clearance Assessments
- Evaluation and Development of cutting edge technologies for detection and identification of adventitious agents of any type, i.e. viruses, bacteria, mycoplasma, fungi or protozoa arising from a variety of substrates including process raw materials and environmental samples
- Technology development, process troubleshooting, as well as qualification and validation of such technologies for use in commercial and clinical manufacturing contamination investigations
- Regulatory Support for issues related to viral safety
- Mitigation of adventitious agent contamination risk
Reporting to the Director of Cellular Sciences, the Senior Scientist will manage a team of scientists and associates and contribute to the strategic direction of the group based on industry trends, future requirements and feedback from key partners as well as regulatory requirements.
- Leads a high performing technical team with diverse scientific disciplines
- Will effectively interface with partners in Process Development, Quality and Regulatory to align on activities in al development stages and compliance
- Takes a proactive role in identifying current advances and trends in detection and identification methods for adventitious agents
- Advance the organizations acumen on GMP compliance and current regulatory trends and expectations.
- Guide and mentor others on day to day performance, long term career development and through change
- Organize and Leverage resources to maximize output while still being very innovative
- Build and maintains strong working relationships with relevant internal and external customers and partners
- Executes with a sense of purpose and drives course corrections where appropriate
- Contributes to regulatory filings, including IND and BLA; as needed assists in answering questions from regulatory authorities
- Support rigorous review of department scientific and regulatory deliverables
- Recruit and retain highly capable staff that can deliver in a highly matrixed and dynamic environment
In our mission to serve patients, speed is absolutely critical. Were rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team working toward our mission of advancing high potential programs for cancer patients around the world.
Doctorate degree and 2 years Scientific experience
Masters degree and 5 years Scientific experience
Bachelors degree and 7 years Scientific experience
- PhD in Virology or Microbiology with extensive experience in molecular biology
- 3+ years industrial experience in the area of safety of biotechnology derived therapeutics from adventitious agents with an emphasis on viral safety
- Well versed in, and with demonstrated and extensive hands-on experience with general cell and molecular biology techniques such as cell culture maintenance, in vitro viral infections, nucleic acid isolation, cloning techniques, and advanced PCR methodologies
- Familiar with current advances and trends in detection and identification methods for adventitious agents as they relate to production of protein therapeutics in mammalian cell culture systems
- Advanced scientific/technical reading/writing skills, advanced scientific analysis skills, and advanced laboratory work skills
- Demonstrated problem solving ability and strong oral and written communication skills.
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.