Engineer - Drug Substance Technologies and Engineering.

Cambridge, MA, US
Jul 18, 2019
Required Education
High School or equivalent
Position Type
Full time
Work 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 Engineer in the Drug Substance Technologies and Engineering Team, you will be responsible to support 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 qualified candidate will be well versed in chemical engineering fundamentals with the ability to apply their skills to drive scalable understanding and implementation of processes that deliver Amgen's pipeline.

You will work with a cross functional group of engineers and scientists through the process development cycle at Amgen and the contract site(s) to ensure successful technology transfer and manufacturing. This includes documentation and oversight activities to support production operations during process execution, equipment commissioning, optimization and scheduling. The ideal candidate will have manufacturing experience and a working knowledge of process development and regulatory requirements to produce synthetic APIs.

Domestic and International Travel: up to 20%

Job Responsibilities include:
  • Provide solutions to a variety of technical problems of moderate scope and complexity.
  • Evaluate (under general supervision), select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
  • Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
  • Initiate and complete routine technical tasks.
  • Function as a technical expert to equipment or systems regarding troubleshooting operations.
  • Perform daily operations when required to meet schedules or to resolve complex problems.
  • Monitor manufacturing processes for performance indicators and operations. Suggest 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 non-conformances, process performance qualification and continued process verification
  • Support non-standard shift organization and extended hours, as per business needs.

Basic Qualifications

Master's degree
Bachelor's degree and 2 years of Engineering or Operations experience

Associate's degree and 6 years of Engineering or Operations experience

High school diploma / GED and 8 years of Engineering or Operations experience

Preferred Qualifications
  • Education background in Chemical Engineering
  • 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of synthetic manufacturing processes
  • Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
  • Experience working with commercial manufacture of biologics using single use technology
  • Basic understanding cGMP requirements
  • Experience building and utilizing first principle models (reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms
  • 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.
  • Regulatory knowledge and interactions
  • Project management skills
  • Strong oral and verbal communication and presentation skills
  • 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.