Manufacturing Science and Technology (MSAT) Senior Scientist, Cell Therapy (Hybrid)

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 to join our MSAT Cell Therapy team (Sr. Scientist, CT MSAT). As a member of the CT MSAT team, you are responsible for successfully transferring processes into GMP-compliant Production, from Process Development to Commercial Manufacturing. As such, you are in direct contact with Lonza’s internal departments and clients, leading and ensuring on-time delivery of technology transfer activities throughout Lonza’s New Product Introduction and Cell Therapy products lifecycle. You are in charge of all MSAT deliverables during Technology Transfer campaigns. You will lead major process deviations, investigations, changes, and corrective and preventive actions (CAPAs), and be accountable for continuously improving the manufacturing processes through leading failure mode and effects analysis (FMEA) and owning process data tracking, tracing and trending.

Key responsibilities:

• Successfully transfer CT processes into GMP production.
• Ensure on-time delivery/readiness of technology transfer (TT) campaigns, collaborating with cross-functional programs teams, including Lonza’s internal departments and clients.
• Act as an independent Subject Matter Expert (SME) and process owner within the CT MSAT group and cross-functional project teams. Lead and provide in-depth technical expertise and scientific knowledge to enable flawless new product introduction (NPI), TTs and GMP-compliant manufacturing of CT products, including all aspects related to those focus areas.
• Functional Lead for CT Process Technology Transfers. Perform detailed reviews of clients processes and generate TT documents to support TT campaigns in collaboration with internal and external stakeholders. Activities include, but are not limited to, performing Fit/Gap analysis and Process Failure Modes and Effects Analysis (FMEA), authoring/reviewing Process Flow Diagrams and Batch Records, creating Bill of Materials, performing process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports.
• Lead and support root cause analysis for major process deviations, CAPAs, Changes, Deviations, Investigations and all other process-related documentation.
• Ensure process scalability and manufacturability and support process validation activities for late-phase production.
• Recommends improvements for MSAT practices and procedures.
• Mentor, coach and guide junior team members throughout NPIs and TT campaigns.

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 with Biologics process development, MSAT or Manufacturing, CMC regulations and international guidelines, including but not limited to the Federal Drug Administration (FDA).
• Knowledge of cell biology, adherent/suspension cell culture, scale-up operations, and aseptic processing for cell therapy products.
• The position requires understanding of GMP knowledge and Technology Transfers (3-4 years)
• Experience with CliniMACS, LOVO and Sepax equipment is highly preferred.
• The position requires experience interacting and collaborating with clients and internal parties, based on professional communication and transparency.
• This position requires experience working in a fast-paced and dynamic environment, demonstrating  professional behavior to unexpected events.
• Work experience in cell therapy products, MSAT, 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 mak