Manufacturing Science and Technology Scientist (Viral Vector)
United States, Houston (Texas)
Our Lonza site in Houston is seeking a Manufacturing Science and Technology Scientist. As a member of the MSAT Team (Manufacturing Science and Technology), you are responsible for the successful transfer of processes into production. As such, you are in direct contact with our clients and Research & Development scientists. You ensure process scalability and manufacturability. You are the person in charge for process integration related aspects during campaign preparation and you are responsible for process supervision and reporting during and after production campaigns. In addition, you will coordinate all process relevant major deviations and process adaptations and you are responsible for continuous improvement of the manufacturing processes.
- The MSAT Scientist will be responsible for the successful transfer of viral vector processes into GMP production. The incumbent will collaborate with cross-functional teams, including Lonza’ s client, Process Development, Manufacturing, Quality Assurance and Program Management to ensure GMP readiness.
- MSAT Scientist will act as a technical Subject Matter Expert (SME) within the MSAT group as well as for the various project teams. The incumbent will provide technical support to General Manufacturing Practices (GMP) execution of the new processes and any deviation investigations, Corrective Action Prevention Plans (CAPAs), and necessary change controls. MSAT Scientists ensure process scalability and manufacturability.
- Client-facing functional Lead for Process Technology Transfers. Performance detailed review of clients and Process Development process and generates technology transfer documents. Performs process monitoring (manufacturing data analysis, summary, and presentation), author campaign summary reports. Recommends improvements for MSAT practices and procedures.
- Supports root cause analysis for major process deviations. Support CAPA and change control processes.
- Management of data and analyzes of various operational parameters.
- Technology transfer activities. The activities include but are not limited to, performing process fit-to-plant, equipment characterization and scale-up, process Failure Modes and Effects Analysis (FMEA)-based risk assessment, creation of Process Flow Diagrams and Bill of Materials, review and approval of production Master Batch Records.
- Bachelor’s Degree required in a field of study such as Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology, or other life science degrees.
- Master of Science degree or PhD in Engineering and/or sciences preferred.
- Experience with Biologics process development, MSAT or Manufacturing.
- Experience with CMC regulations, and international guidelines including but not limited to Federal Drug Administration (FDA)
- Knowledge of cell biology, adherent and suspension cell culture, scale-up and bioreactor operation, chromatography operation, Ultrafiltration/Diafiltration (UF/DF), Tangential Flow Filtration (TFF), and aseptic filling.
- Work experience in viral vector product/process development or manufacturing is a plus.
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.