MSAT Process Engineer/Scientist (mRNA)
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 in Portsmouth, NH has a remarkable opportunity for an experienced Manufacturing Science and Technology (MSAT) Process Engineer to be part of our team that works on the mRNA vaccine. As our Process Engineer, your will be a primary technical support person for large-scale manufacturing processes and is a SME for their role. This role is for someone with prior experience in performing all associated functions with process transfer and process support for large-scale manufacturing.
- Represents Manufacturing Science and Technology (MSAT) on project teams as technical subject matter expert (SME) and interface with customer technical and quality representatives.
- Performs all functions associated with process transfer and process support, e.g. develop process understanding, perform gap analysis / FMEA, generate process models, author / review 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).
- Assesses minor deviations and assesses product quality impacting deviations with assistance. Identifies potential root causes with assistance.
- Performs higher-level data analysis such as out of control, trends, shifts, simple linear regression.
- Authors/reviews/and owns process related documentation (e.g. process descriptions, definitive formulations, batch records, raw material listings, and change controls).
- Bachelor of Science degree in Biotechnology area, Biological Sciences, or Chemical Engineering.
- Significant experience in biotech industry in process development, process scale up, tech transfer or manufacturing.
- Significant experience with large-scale manufacturing support, cGMP and US / EU regulations.
- Strong knowledge of protein structure, chromatography, Ultrafiltration/Diafiltration, 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 interpersonal 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.