Manufacturing Science and Technology Senior Scientist (Viral Vector)
United States, Houston (Texas)
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.
Our Lonza site in Houston is seeking a Manufacturing Science and Technology Senior 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 Senior Scientist will be responsible for the successful transfer of viral vector and/or viral cell therapy processes into GMP production. The incumbent will collaborate with cross-functional teams, including Lonza’ s client, Process Development, Manufacturing, and Program Management to ensure on time delivery of technology transfer activities. The activities include but are not limited to, performing process fit-to-plant, equipment characterization and scale-up, Failure Modes and Effects Analysis (FMEA)-based risk assessment, review and approval of production batch records.
- MSAT Senior 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 Sr. Scientists ensure process scalability and manufacturability and will support process validation activities for late phase production. May provide guidance on process transfer and support activities to junior members of the team.
- Functional Lead for Process Technology Transfers. Performance detailed review of clients and Research and Development (R&D) process and generates, in collaboration with R&D, technology transfer documents. Performs Fit/Gap analysis and process Failure Modes and Effects Analysis (FMEA), author / review Process Flow Diagrams and Batch Records, perform process monitoring (manufacturing data summary and analysis, data 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.
- 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 preferred or PhD in Engineering and/or sciences preferred.
- Substantial experience with Biologics process development, MSAT or Manufacturing.
- Substantial 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 cell therapy product/process development or manufacturing is a plus.
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.