Process Development Sr. Engineer - Drug Product

Thousand Oaks, CA, US
Sep 08, 2019
Required Education
High School or equivalent
Position Type
Full time
As part of the Drug Product Technologies group, the process development Sr. Engineer will provide support for Amgen's biologics drug product and process design, commercialization and lifecycle management. The Sr. Engineer will work closely with 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 Sr Engineer will operate in a fast-paced, matrixed environment and collaborate successfully with colleagues within DPT and cross-functionally to develop and proceduralize 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.

A successful candidate will be able to work independently, taking responsibility of projects and self-managing their work packages with appropriate communication and escalation. A successful candidate will thrive in a cross-functional team environment, adeptly collaborating and liaising with colleagues within DPT as well as partner organizations across Operations. Finally, a successful candidate will be driven to find efficient approaches to solve relevant problems and will thereby deliver value-adding and agile solutions to Amgen Process Development.

The Sr Engineer 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 sites

Key Responsibilities:
  • Based on a comprehensive knowledge of process/product commercialization activities, develop and proceduralize tools to improve the efficiency and harmonization of business processes, including but not limited to standardized study designs, prior knowledge assessments, lessons learned, template protocols/reports.
  • Partner with unit operations owners and subject matter experts on the above
  • Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of 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.
  • Participate as required in project activities.
  • Coordinates and organizes resources needed to complete tasks

Basic Qualifications:
  • Doctorate Degree or Doctorate Degree completed by June 2019
  • 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

Preferred Qualifications:
  • 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
  • Experience in technical transfer of drug product processes to 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 cross-functional teams to advance complex projects to completion and influencing decisions
  • Experience in drug product manufacturing environment and knowledge of cGMPs

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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.

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.

Join Us

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.