Senior Engineer, Drug Substance Technologies and Engineering

Location: Cambridge, MA or Thousand Oaks, CA

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.

For this role as an Senior Engineer in the Drug Substance Technologies and Engineering Team, responsibilities includes leading the technical transfer and engineering oversight of Amgen's drug substance synthetics processes at Contract Manufacturing Organizations (CMOs) across all phases of development and commercialization. The position will also work with a cross functional group of engineers and scientists through the process development cycle at Amgen and contract site(s) to ensure successful technology transfer, manufacturing and regulatory support. The Senior Engineer will also use experience in the oversight and/or operations of production facilities; including process execution, equipment utilization, and optimization.

The ideal candidate should be well versed in tech transfer, process development, scale up, modeling, optimization, characterization, regulatory support and commercial production of synthetic organic molecules.

Domestic and International Travel: up to 20%

Job Responsibilities include:

• Initiate and complete standard practices for technology transfer of synthetic processes which include drafting process transfer documents, process fit assessments, manufacturing support, risk analysis and process documentation.
• Represent organization within a cross functional team to ensure deliverables aligned with tech transfer timeline are achieved.
• Evaluate, select and apply standard engineering techniques and procedures to provide solutions to a variety of technical chemical and process issues.
• Monitor manufacturing processes for performance indicators and operations. Lead problem resolution and provide troubleshooting guidance.
• Apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
• Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for processes and/or system modifications.
• Communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments.
• Contribute to key regulatory and quality activities such as NDAs, non-conformances, process performance qualification and continued process verification.

Basic Qualifications

Doctorate Degree

OR

Master's degree and 3 years of Engineering or Operations experience

OR

Bachelor's degree and 5 years of Engineering or Operations experience

OR

Associate's degree and 10 years of Engineering or Operations experience

OR

High School Diploma/GED and 12 years of Engineering or Operations experience

Preferred Qualifications

• Engineer with 5+ years of experience in providing and driving engineering deliverables for pharmaceutical processes and product development
• Experience related to process development, technology transfer, scale-up and manufacturing of synthetic molecules in regulated environment. This includes technical support for nonconformance investigations and other commercial support activities
• Ability to critically evaluate chemical processes for identification of process improvements and requirements necessary for scale up and tech transfer
• Possess strong understanding of regulatory and cGMP requirements
• Knowledge of analytical techniques and solid-state characterization with fluency in a wide variety of analytical techniques including HPLC, GC, MS, NMR, FTIR, LOD, TOC, particle size determination, etc.
• Able to apply engineering principles and advanced statistical analysis in-order to solve processing issues and evaluate opportunities for process improvements
• Experience building and utilizing first principle models (reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms
• Experience in working closely with process development chemists, formulation scientists and analytical chemists to generate and interpret data to provide enhanced understanding and guidance for synthesis and unit operations
• Contribute to key regulatory and quality activities such as non-conformances, process performance qualification and continued process verification
• Experience with Quality by Design and Process Analytical Technologies, applied to pharmaceutical development
• Strong communication and presentation skills, excellence in team work, mature process fit proficiency, command of operations plant safety practices
• Fluency in German and/or Italian a plus

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 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.