Senior Process Development Engineer

2 days ago

Thousand Oaks, California, United States Aditi Consulting Full time
Job Title: Senior Process Development Engineer

We are seeking a highly skilled Senior Process Development Engineer to join our global Process Development organization. As a key player in our team, you will be instrumental in ensuring the highest standards of process performance while leading innovative process improvement strategies.

Key Responsibilities:

  • Develop and characterize drug product processes and transfer new technologies to commercial sterile fill/finish sites.
  • Provide process development expertise for commercial drug product processing in areas such as Sterile processing, Process Characterization, Tech Transfer, and Validation.
  • Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer.
  • Interface with manufacturing and support functions to provide robust and coordinated support to manufacturing.
  • Lead and participate in global cross-functional teams to influence and drive change, efficiency, and foster strong relationships.

Requirements:

  • Advanced degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry, or Biotechnology.
  • 5+ years of drug product process development experience in the pharmaceuticals/biotechnology industry.
  • Knowledge of end-to-end development for liquid and lyophilized drug products in various presentations.
  • Experience with unit operation for parenteral manufacturing, specifically lyophilisation.
  • Strong skills in applying fundamental engineering and scientific principles to design and implement protein freeze-thawing, filtration, mixing, filling, and/or lyophilisation processes.

Preferred Qualifications:

  • Project management skills, including the ability to manage multiple projects and evaluate project resource requirements.
  • Strong knowledge of Quality systems, Drug Product Manufacturing, and Validation.
  • Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.

What We Offer:

  • Competitive pay rate range.
  • Medical, dental, vision, PTO benefits, and ancillaries may be available for eligible employees.

About Aditi Consulting:

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.

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