MSAT Project Manager (Documentation and Technology Transfer) - REMOTE

United States, Walkersville (Maryland)

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza is actively seeking an MSAT Project Manager (Documentation and Technology Transfer) to join the Cell and Gene Therapies  (CGT) group; but will be REMOTE based in the USA.  The MSAT Project Manager (Documentation and Technology Transfer) authors and owns local and global documents. They manage document life cycles and the standardization and harmonization of Operations across the Network. In addition, the MSAT Project Manager supports training, complex technical investigations, evaluation of new processes/technologies for facility fit, and transfer of non-standard or complex processes to GMP Manufacturing.

Key responsibilities:

  • Author local and global documentation. Serve as document owner as needed.
  • Manage the standardization and harmonization of Operations across the Network (e.g. aseptic and technical training content, APSs, MBRs, SOPs, protocols, reports, etc.).
  • Manage document project lifecycles.
  • Assess documentation, processes, and programs for continuous improvement, error reduction, and increased operator aseptic and process knowledge and skill.
  • Establish, maintain, and report metrics to measure the effectiveness of harmonization.
  • Provide classroom and hands-on administrative, aseptic, and technical training as needed.
  • Act as a mentor to junior staff.
  • Perform facility fit analysis. Evaluate new processes/technologies for operational application, capability, and feasibility.
  • Manage transfer of non-standard or complex processes to GMP Manufacturing.
  • Support complex technical investigations, root cause analysis, and identification/implementation of corrective/preventive actions.
  • Lead Risk Assessments and FMEAs. Develop process models and process flow diagrams.
  • This position requires excellent oral and written communication skills, across all levels of the organization and ability to authoritatively discuss technical issues with internal and external customer experts.
  • This position requires travel to CGT Network sites and project teams (up to 20%).

Key requirements:

  • Bachelor’s Degree in a Life Sciences discipline
  • Substantial experience drafting and designing GMP documentation (aseptic and technical training content, Aseptic Process Simulations, MBRs, SOPs, protocols, reports, etc.)
  • Substantial experience managing project life cycles (documentation and/or technology transfer)
  • Substantial GMP compliance knowledge
  • Substantial cell culture, molecular biology OR biotech/biopharma laboratory and/or manufacturing experience (preferably in a cGMP manufacturing environment)
  • Significant experience training in an individual and/or group setting
  • Computer software skills including Microsoft Office (e.g. Word, Publisher, Excel, Project)
  • Database and spreadsheet creation and maintenance
  • Ability to manage multiple projects
  • Root cause analysis
  • Gap analysis
  • FMEA and risk assessments

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R24134