Engineer - Process Development

Amgen Inc.

3.6

(9)

Thousand Oaks, CA

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-183816

    Position summary

    f development and commercialization. Chemical engineering fundamentals will be applied to generate process understanding and implement scalable drug substance processes that deliver Amgen's pipeline of diverse synthetic and hybrid modalities.

    The Engineer will partner with a multi-functional group of engineers and scientists to develop and optimize synthetic unit operations aligned with the intended phase of technology transfer and manufacturing. This work will include experimental design and execution, data analysis, process risk analysis, process characterization, facility fit assessment, and in-plant support of production operations during process execution and equipment commissioning.

    • In a team setting and with limited supervision, design and implement standard experimental, modeling and engineering techniques for process optimization, characterization, and scale-up of chemical processes in innovative facilities.

    • Initiate and complete experimental techniques in the lab, kilogram-scale facility, and manufacturing environments.

    • Author documents for process understanding, technical transfer, risk assessment, facility fit, and process development and characterization.

    • Serve as a technical expert for lab equipment or systems.

    • Be an active participant in daily production or development operations when required to meet schedules or to resolve sophisticated problems.

    • Routinely monitor manufacturing processes for performance indicators and operations. Conceptualize resolutions to processing challenges, provide troubleshooting guidance and recommend process improvements.

    • Apply engineering principles and statistical analysis, including design of experiments, to solve process issues and evaluate opportunities for process improvements.

    • Communicate and collaborate with External Supply, Manufacturing, Process Development, and Quality departments.

    • Contribute to key regulatory and quality activities such as non-conformances, process performance qualification, and continued process verification.

    Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is a teammate with these qualifications.

    Basic Qualifications:

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

    • Associate's degree and 4 years of Engineering or Operations experience

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

    • Master's degree

    Preferred Qualifications:

    • Academic background in Chemical Engineering

    • 2+ years of experience in a Process Development or Process Engineering environment, with specific experience in the implementation and support of synthetic or hybrid manufacturing processes

    • Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale

    • Basic understanding of cGMP requirements

    • Experience building and applying first-principle models (e.g., 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 techniques including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc.

    • Background in statistical analysis/DoE

    • Solid understanding of standard plant operations and safety practices

    • Project management skills

    • Strong verbal communication and presentation skills

    Thrive

    What you can expect of us

    As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

    In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

    Apply now for a career that defies imagination

    Objects in your future are closer than they appear. Join us.
    careers.amgen.com

    Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

    We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

    #obesity

    Salary Range
    87,178.00 USD - 107,393.00 USD

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging