MSAT Sr. Scientist

United States, Portsmouth (New Hampshire)

Today, Lonza is a global leader in life sciences operating across three continents. 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.

This challenging position is available in the process transfer and support group of the Manufacturing Sciences and Technology Department (MSAT) in our Portsmouth facility. This position is responsible for being the primary technical support person for manufacturing processes. The supervisor provides direction and oversight, as this level of Process Scientist is expected to have a good grasp of the requirements of the role. The individual is a subject matter expert in cell therapy manufacturing processes; it is expected that questions on tasks or issues will be raised by this individual when clarification or greater technical expertise is required. This individual may provide supervision and guidance to other MSAT personnel. Position will be dependent  on relevant experience.

Key Accountabilities and Duties:

  • Performs all functions associated with process transfer and process support, e.g. develop process understanding, perform gap analysis / FMEA, generate process models, author / review Process Descriptions and Batch Records, author / review planned deviations and change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports, perform activities for lot release (assess deviations and process changes).
  • May provide guidance on process transfer and support activities to junior members of the team.
  • Assess all major deviations including those that impact product quality. Identifies potential root causes using a systematic approach. Experience using variety of problem solving tools e.g. Fishbone, Kepner-Tregoe etc. Able to identify potential solutions. Performs or is able to understand all types of complex data analysis such as multiple linear regression analysis, ANOVA, multivariate analysis.
  • Authors and reviews process descriptions, definitive formulations, batch records, raw material listings, change controls independently and authors/reviews/modifies the corresponding templates. Assesses change controls for impact of any change to the process, equipment or procedures that can affect process performance and product quality. Supports documentation preparation for regulatory purposes.
  • Represents MSAT on project teams and interfaces with customer technical and quality representatives. Represents MSAT on internal teams (e.g. Deviation and Run Daily Management System meetings).
  • Participates in Customer and Regulatory Audits.

Minimum Required Qualifications/Skills:

  • Bachelor of Science degree in Biological Sciences or Biomedical/Chemical Engineering
  • Extensive biotech industry experience supporting allogeneic and /or autologous cell therapy process development / process scale up  or manufacturing. Experience with cell therapy manufacturing support, current Good Manufacturing Practices, US / EU regulations.
  • Intermediate knowledge of cell culture for allogeneic and /or autologous cell therapy processes, cell biology, scale up and intermediate knowledge of statistical data analysis. Familiarity with cell therapy manufacturing, current Good Manufacturing Practices and US/EU regulations.
  • Position will be dependent  on relevant experience.

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: R44420