Cell Therapy MSAT Senior Process Engineer
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.
Lonza in Portsmouth, NH is searching for a Sr. Cell Therapy Process Engineer to join our Manufacturing Sciences and Technology team (MSAT). As our Cell Therapy Sr. Process Engineer, you will responsible for being the primary technical support person for Cell Therapy manufacturing processes. You will be working on more than three manufacturing processes and performing more than one process technical transfer. You will also be one of our subject matter expert for the role.
- Performs all functions associated with cell therapy process technology transfer and process monitoring and support, e.g. develop process understanding, generate bill of materials (BOM), perform gap analysis / failure mode effect and analysis (FMEA), generate process models author/review detailed process flow diagrams (DPFD), perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports, and perform activities for lot release (assess deviations and process changes).
- Assess all major deviations including those that impact product quality. Identifies potential root causes using a systematic approach with experience using variety of problem solving tools e.g. Fishbone, Kepner-Tregoe etc. 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. Reviews/authors DPFDs as needed. Assesses change controls for impact of any change to the process, equipment or procedures that can affect process performance and product quality.
- Runs and leads MSAT joint technical team meetings and other joint team meetings as needed.
- Bachelor of Science or advanced degree in Biological Sciences or Biochemical/Biomedical Engineering applicable to Cell Therapy.
- Working experience with cell therapy processes with a Ph.D in the field of cell therapy or a degree applicable to cell therapy.
- Significant experience with cell therapy processes with an M.S. or B.S. in Biological Sciences or a degree applicable to cell therapy.
- Significant biotech industry experience supporting allogeneic and /or autologous cell therapy process development / process scale up / tech-transfer/manufacturing, preferably with either CAR-T cell or stem cell process development or manufacturing experience.
- Significant experience with cell therapy manufacturing support, current Good Manufacturing Practices (GMP), US / EU regulations.
- Significant knowledge of cell culture for allogeneic and /or autologous cell therapy processes, cell biology, drug product, scale up and intermediate knowledge of statistical data analysis. Familiarity with cell therapy manufacturing, current Good Manufacturing Practices and US/EU regulations
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.