Manufacturing Science and Technology (MSAT) Senior Scientist
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.
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.
Key responsibilities:
- 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 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.
- 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
- Must know and follow safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site.
Key requirements:
- 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 (6 plus years) work experience in suspension cell culture, scale-up and bioreactor operation (e.g. Ambr, Thermo, Applikon, WAVE, etc), perfusion, Tangential Flow Filtration (TFF) for Ultrafiltration/Diafiltration (UF/DF).
- Substantial (6 plus years) work experience with Biologics process development, MSAT or Manufacturing.
- Work experience in viral vector gene therapy product/process development and/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.
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.