Principal Engineer - Pivotal Drug Product Technologies

Company: Amgen
Location: Thousand Oaks
Posted on: March 22, 2020

Job Description:

As part of the Drug Product Technologies (DPT) group, the process development Principal Engineer will provide support for Amgen's biologics drug product and process design, commercialization and lifecycle management. The Principal Engineer will lead a team of engineers and scientists responsible for the technical aspects of Amgen's drug product and process development. In addition to performing process characterization and formulation studies, this role will also focus on development of tools that will enhance efficiency and robustness of our technical data packages.The Principal Engineer will operate in a fast-paced, matrixed environment and collaborate successfully with colleagues within DPT and cross-functionally to develop and operationalize lean study designs for process characterization, create and implement tools for data acquisition, analysis, and modelling, and improve operational efficiency via alignment of work across teams, and tailoring output to intended user requirements. This individual will work independently, leading projects and self-managing work packages with appropriate communication and escalation. The Principal Engineer will be driven to find efficient approaches to solve relevant problems and will thereby deliver value-adding and agile solutions to Amgen Process Development. This individual will need to stay current on 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 sitesKey Responsibilities:

• Based on a comprehensive knowledge of process/product commercialization activities and in partnership with other subject matter experts, develop and operationalize business processes to improve the efficiency and harmonization of the organization, including but not limited to standardized study designs, prior knowledge assessments, lessons learned, template protocols/reports.
• Measure the effectiveness and adherence to relevant business processes and report these to management.
• Lead cross-functional drug product team(s) as needed.
• Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of Investigational New Drug (IND) and marketing application submissions.
• Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.
• Influence the planning, design, execution, and documentation of laboratory studies related to drug product design, formulation development, and process development in support of commercialization and life cycle management.
• 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.
• Deliver progress reports and presentations to ensure management awareness and engagement of the current status, progress, and future program and functional needs.
• Coordinate and organize resources needed to complete tasks.Basic Qualifications:Doctorate degree and 2 years of Engineering and/or Operations experienceORMaster's degree and 6 years of Engineering and/or Operations experienceORBachelor's degree or and 8 years of Engineering and/or Operations experienceORAssociate's degree and 10 years of Engineering and/or Operations experienceORHigh school diploma / GED and 12 years of Engineering and/or Operations experiencePreferred Qualifications:
  • Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related discipline
  • 10+ years relevant experience
  • Experience in designing drug product unit operations such as freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection
  • Experience leading multiple cross functional drug product teams and/or multiple technical transfers of drug product processes to commercial manufacturing sites
  • 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.
  • Demonstrated ability in providing leadership to multi-functional teams to advance complex projects to completion and influencing decisions
  • Experience in drug product manufacturing environment and knowledge of cGMPsJoin UsIf 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.

Keywords: Amgen, Thousand Oaks , Principal Engineer - Pivotal Drug Product Technologies, IT / Software / Systems , Thousand Oaks, California