Manufacturing Science and Technology Senior Process Development Scientist
Portsmouth, New Hampshire
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 is looking for an experienced Senior Process Development Engineer or Scientist. As our Process Development Engineer or Scientist, you will be responsible for being the primary technical support person for manufacturing processes. This person has experience with more than three manufacturing processes and performing more than one process transfer. The supervisor provides direction and oversight, as this level of Process Development Engineer/Scientist is expected to have a good grasp of the requirements of the role. The individual is a subject matter expert for four aspects of the role and 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 immediate supervision or assign tasks to a unit or group of employees.
- 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 / failure mode effects 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).
- Assesses all major deviations including those that impact product quality as well as post lot release deviations that may impact multiple products.
- Identifies potential root causes using a systematic approach. Expertise in use / application of variety of problem solving tools (e.g. Fishbone, Kepner-Tregoe etc.).
- Able to identify potential solutions and lead multidisciplinary teams in developing and implementing solutions.
- Performs and is able to understand and interpret all types of complex data analysis such as multiple linear regression analysis, ANOVA, multivariate analysis and identify applications where appropriate.
- Authors and reviews process descriptions, definitive formulations, batch records, raw material listings, change controls independently and authors/reviews/modifies the corresponding templates.
- Bachelor of Science degree in Biological Sciences, or Biomedical/Chemical Engineering.
- Substantial experience in biotech industry in process development, process scale up, tech transfer or manufacturing.
- Significant experience with large scale (2 KL + experience a plus) manufacturing support (mammalian preferred), cGMP and US / EU regulations.
- Substantial knowledge of cell biology, cell culture, scale-up and mass transfer, bioreactor operation, disc stack centrifugation, filtration and working knowledge of statistical data analysis.
- Significant experience working in a customer service oriented role with strong attention to detail and excellent time management skills.
- Strong communication skills that are accustomed to working in a fast paced environment.
- 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.