MSAT Drug Product Sr. Scientist

Lonza • Houston, TX

258d

About The Position

At Lonza's Houston site, we provide a remarkable opportunity for a Sr. Scientist in MSAT. Join our ambitious MSAT Team, where you will play a vital role in the successful transfer of drug product processes into production. By collaborating with clients, manufacturing, and R D scientists, you will ensure process scalability and manufacturability. This role involves leading all aspects of process integration during campaign preparation and coordinating processes during and after production campaigns. You will also address major deviations, process adaptations, and drive continuous improvement of manufacturing processes.

Requirements

• Bachelor's Degree in a science-related field.
• 6+ years of proven experience in aseptic processing, MSAT, or manufacturing.
• Deep understanding of CMC regulations and international guidelines, including FDA standards.
• Proficiency in aseptic filling of parenteral drug products.
• Previous experience in drug product/process development or manufacturing is an advantage.

Responsibilities

• Responsible for the flawless transfer of drug product filling, inspection, labeling, and packaging processes into GMP production.
• Collaborate cross-functionally with clients, Process Development, Manufacturing, Quality Assurance, and Program Management to ensure GMP readiness.
• Act as a technical Subject Matter Expert (SME) for the MSAT group and various project teams, providing technical support for GMP execution and deviation investigations.
• Lead technology transfer activities, conduct in-depth reviews, and develop technology transfer documents.
• Conduct process monitoring, data analysis, and campaign summary reporting, recommending improvements for MSAT practices and procedures.
• Manage data analysis of various operational parameters.
• Complete technology transfer activities, such as process fit-to-plant, equipment characterization, scale-up, FMEA-based risk assessment, and creation of Process Flow Diagrams and Bill of Materials.

Benefits

• Performance-related bonus
• Medical and dental coverage
• 401k plan
• Life insurance
• Short-term and long-term disability insurance
• Employee assistance program
• Paid time off (PTO)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree