Amgen Process Development Senior Engineer in Thousand Oaks, California
Amgen is currently seeking a Process Development Sr. Engineer for our Pivotal Drug Product Technologies Group in Thousand Oaks, CA. This group is responsible for late stage drug product formulation and fill/finish process development for various biological modalities (large molecule, RNA, virus). Additionally, the position requires expertise in data analysis and the use of statistical models to inform decisions throughout drug product development. The Sr. Engineer will provide technical and project leadership while integrating information generated by multi-functional teams to ensure success through the commercialization process. The Sr Engineer will need to stay ahead of the latest developments/trends in the industry and scientific community to foster innovation and to meet future business needs.
This position requires (up to 10%) travel to domestic and international sites.
Work independently, taking ownership of projects and self-managing work packages with appropriate communication and escalation
Plan, design, execute, and document laboratory studies related to formulation and fill/finish process development in support of product commercialization and life cycle management
Apply basic science/engineering skills and first principle modeling to solve technical problems
Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in life-cycle management
Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software
Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements
Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
Deliver progress reports and presentations to ensure management awareness and engagement of the current status, advancement, and future program functional needs
Find efficient approaches to solve relevant problems and will thereby deliver value-adding and agile solutions to Amgen Process Development
Work in a cross-functional team environment, adeptly collaborating and liaising with colleagues within Drug Product Technologies, as well as partner organizations across Operations
Ability to travel domestically and internationally up to 10% of the time.
Doctorate Degree or Doctorate Degree completed by August 2020
Master’s Degree and 3 years of Engineering and/or Operations experience
Bachelor’s Degree and 5 years of Engineering and/or Operations experience
Associate’s degree and 10 years of Engineering and/or Operations experience
High school diploma/GED and 12 years of Engineering and/or Operations experience
Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related discipline
5+ years relevant experience
Experience in designing drug product unit operations such as freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection
Strong skills in applying fundamental engineering and scientific principles to process design
Project management skills, including the ability to manage multiple projects and evaluate project resource requirements.
Experience with coding/scripting for automated data analysis and modeling
Experience with data visualization tools or packages, such as Tableau or Spotfire
Experience that includes elements of new product development, formulation development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
Proven ability to learn and act on dynamic information at a rapid pace
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.
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.