Process Development Engineer

4 days ago

Thousand Oaks, California, United States ACL Digital Full time
Job Title: Senior Engineer

Location: Thousand Oaks, CA

Duration: 12 Months

Onsite at ATO - 3 days onsite

We are seeking a highly skilled Senior Engineer to join our global Process Development organization. As a key player, you will be instrumental in ensuring the highest standards of process performance while driving innovation in large and small molecule drug product manufacturing.

Key Responsibilities:

  • Act 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.
  • 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 specific 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. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
  • Lead and participate in global cross-functional teams working effectively in a highly matrixed team environment to influence and drive change, efficiency, and foster strong relationships.
  • Troubleshoot issues with drug product processing technologies and equipment. Champions use of data-driven analyses and visualizations. Investigates to determine true root cause.
  • Authors and reviews guideline documents, technical protocols, reports, product impact assessments and regulatory submissions
  • Identifies and implements operational opportunities for current and new sterile operations.

Preferred Qualifications:

  • 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. Knowledge of protein biochemistry with regard to chemical and physical stability.
  • 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. Excellent communication skills are essential for this role, as well as a demonstrated proficiency with the principles of Technical Writing.

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