Senior Process Development Engineer

3 days ago

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

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

Key Responsibilities:

  • Acts as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in formulation, filtration, filling (vials/syringes/devices) and lyophilization of parenteral products.
  • Develops and characterizes drug product processes and transfers new technologies to commercial sterile fill/finish sites.
  • Provides process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation.
  • Supports commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer.
  • Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.

Requirements:

  • Advanced degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related field.
  • 10+ years of drug product process development experience in the pharmaceuticals/biotechnology industry.
  • Knowledge of/hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations.
  • Experience with unit operation for parenteral manufacturing (i.e. filling, filtration, mixing, etc.), specifically lyophilisation would be an advantage.
  • Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling and/or lyophilisation processes.
  • 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.

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