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 Manufacturing Science and Technology (MSAT) Senior Process Scientists to join our expanding team! Our Senior Process Scientist’s primary responsibility is to be a Subject Matter Expert (SME) for large-scale downstream manufacturing processes. 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. We are looking specifically for a Cell Therapy Sr. Process Engineer, where 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. Key responsibilities for that role are below:
- Represents Manufacturing Science and Technology (MSAT) on project teams as technical subject matter expert (SME) and interface with customer technical and quality representatives.
- Develops process understanding and expertise.
- Authors/reviews/and owns process related documentation (ex. process description and batch records).
- Authors/reviews change controls (including managing the implementation of the change as the assigned change agent).
- Monitors and reports on process performance (manufacturing data analysis and delivery of data in the form of live presentations).
Key responsibilities for Cell Therapy
- 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 degree in Biotechnology area, Biological Sciences, or , Biochemical/Biomedical Engineering applicable to Cell Therapy or Chemical Engineering
- Significant experience with cell therapy processes with an M.S. or B.S. in Biological Sciences or a degree applicable to cell therapy preferred
- Working experience with cell therapy processes with a Ph.D in the field of cell therapy or a degree applicable to cell therapy preferred.
- Significant 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.
- Significant knowledge of cell biology, protein structure, scale up, chromatography, Ultrafiltration/Diafiltration, virus filtration 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.
- Practices safety awareness at all times and considers impact of actions prior to executing activities
- 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.