Manufacturing Scientist and Technology (MSAT) Senior Scientist (Viral Vector)

United States, Houston (Texas)

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:

• Functional Lead for Process Technology Transfer:

The MSAT Upstream Sr. Scientist will be responsible for the successful transfer of Upstream Viral Vector Processes into GMP production. The incumbent will collaborate with cross-functional teams including Process Development (PD), Manufacturing, Quality Assurance, Supply Chain, and Program Management among others to ensure on time delivery of Technology Transfer activities. The MSAT Upstream Sr. Scientist will also represent Lonza at client facing meetings and provide guidance and support to junior team members on MSAT activities.

• Technical Upstream Subject Matter Expert (SME):

The incumbent will act as Upstream SME within the MSAT team as well as for other Lonza teams. The activities include but are not limited to, performing process fit-to-plant, and Failure Modes and Effects Analysis (FMEA)-based risk assessment,  equipment characterization and scale-up, characterizing and scaling-up equipment, authoring and reviewing Process Flow Diagrams, Bill of Materials, and reviewing and approving Production Batch records. The incumbent will provide technical support to GMP execution of the new processes and critical unit operations and lead/support Deviation Investigations, Corrective Action Prevention Plans (CAPAs), and Change Controls.

• Data Management:

The MSAT Upstream Sr. Scientist will perform detailed review of processes from Clients and PD of various operational parameters. The incumbent will generate Technology Transfer documents (e.g. protocols, reports, process summary), perform process monitoring (manufacturing data analysis, summary, and presentation), author campaign summary reports and recommends improvements for MSAT practices and procedures.

Key Requirements:

•Bachelor’s Degree required in a field of study such as Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology, or other life science fields.

•Master of Science or PhD in Chemical Engineering or other life sciences is preferred.

• Substantial 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).

•Experience with Biologics Process Development, Technology Transfer, MSAT and/or Manufacturing is preferred.

•Work experience in viral vector gene therapy product/process development and/or manufacturing is desired.

•Knowledge of CMC regulations, and international guidelines including but not limited to Federal Drug Administration (FDA) is desired.

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.

Reference: R28970