MSAT Drug Product Sr. 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.

Job Description:

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.

• 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.

• 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.

Compensation for the role will depend on a number of factors, including the successful candidate’s qualifications, skills, competencies, experience, and job-related knowledge. Full-time employees receive a comprehensive benefits package including performance-related bonus, medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.

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.