Lonza - Portsmouth, NH

posted 4 months ago

Full-time - Senior
Portsmouth, NH
Professional, Scientific, and Technical Services

About the position

Lonza in Portsmouth, NH is seeking a dedicated Manufacturing Science and Technology (MSAT) Associate Principal Scientist or Process Engineer to join our team. In this pivotal role, you will serve as a Subject Matter Expert (SME) for Cell and Gene Therapy (CGT) manufacturing processes, playing a crucial part in addressing and resolving key process issues. The ideal candidate will have substantial experience in transferring and supporting processes from the initial run in the plant through to Process Performance Qualification (PPQ) campaigns and commercial campaigns. Your expertise will be instrumental in ensuring the successful execution of these processes, which are vital to our mission of improving lives through innovative biopharmaceutical solutions. As a technical lead for technology transfer, validation, and lifecycle management initiatives, you will represent MSAT on project teams, interfacing with customer technical and quality representatives. Your responsibilities will include developing a deep understanding of the processes involved, authoring and reviewing process-related documentation, and managing change controls as the assigned change agent. You will also monitor and report on process performance through manufacturing data analysis, delivering insights in the form of live presentations. This position is an individual contributor role, meaning you will not have direct reports, allowing you to focus on your technical contributions and expertise. At Lonza, we believe that our people are our greatest asset. We encourage our employees to take ownership of their careers and contribute their ideas, big and small, to improve the world. We are committed to ethical practices and the well-being of our employees and the environment, ensuring that our success is achieved responsibly and sustainably. Join us in making a meaningful difference in the lives of millions around the globe.

Responsibilities

  • Serve as a technical lead for technology transfer, validation, and lifecycle management initiatives.
  • Represent MSAT on project teams as technical subject matter expert (SME) and interface with customer technical and quality representatives.
  • Develop process understanding and expertise.
  • Author, review, and own process-related documentation.
  • Author/review change controls including managing the implementation of the change as the assigned change agent.
  • Monitor and report on process performance through manufacturing data analysis and delivery of data in the form of live presentations.

Requirements

  • Minimum of Bachelor of Science degree required, preferred in Biotechnology area, Biological Sciences, or Chemical Engineering.
  • 10+ years of experience in biopharmaceutical industry supporting manufacturing science and technology related functions, including experience with biotech, process development, process scale up, tech transfer and/or manufacturing.
  • Strong knowledge of aseptic technique and cell culture, with experience in cell and gene therapies required.
  • Strong communication skills, able to clearly express ideas and points of view both verbally and in writing, with good interpersonal skills.
  • Commitment to safety awareness at all times and consideration of the impact of actions prior to executing activities.
  • Ability to share 24/7 on-call support while processes are being manufactured.
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