MSAT Cell Therapy Process Engineer/Scientist
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 looking for an experienced Manufacturing Science and Technology (MSAT) Cell Therapy Process Engineer/Scientist to join our team! Our Process Engineer/Scientist’s main responsibility is to be the primary technical support team member for our Cell Therapy manufacturing process.
- Process Transfer and Process Support; Performs all functions associated with process transfer and process support, e.g. develop process understanding, generate BOM, perform gap analysis / FMEA, generate process models author/review detailed process flow diagrams (DPFDs), 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).
- 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.
- Assesses change controls for impact of any change to the process, equipment or procedures that can affect process performance and product quality.
- Bachelor of Science degree in Biotechnology area, Biological Sciences, or Chemical Engineering.
- Significant experience in biotech industry in process development, process scale up, and tech transfer.
- Significant experience with large scale (2 kL + experience a plus) manufacturing support (mammalian preferred), cGMP and US / EU regulations.
- Significant knowledge of cell biology, protein structure, scale up, and basic knowledge of statistical data analysis.
- Strong communication skills. Able to clearly express ideas and point of view both verbally and in writing. Has good inter personal skills. Shows commitment and dedication and strives to be ahead of schedule.
- Ability to share 24/7 on-call support while process is being manufactured.
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.