Key Accountabilities:

• Manage a portfolio of commercial drug products and intermediates throughout the drug product life cycle, including technology transfer, process validation, and commercial manufacturing.
• Lead the commercialization of products at the Lonza – Tampa site, understanding the requirements for successful product launch.
• Develop the manufacturing facility’s systems and capabilities to support a world-class product portfolio in clinical development.
• Design and implement projects aimed at improving safety, quality, and operational efficiency.
• Balance technical, operational, and regulatory requirements to successfully implement strategic business initiatives within manufacturing operations.
• Provide leadership and mentorship to develop the MSAT team, identifying growth areas and crafting growth plans.
• Act as the project lead for commercial products, coordinating technical strategy for process validation and continuous improvements.
• Apply chemical and engineering fundamentals to ensure flawless process execution.
• Lead investigations to support root cause analysis and define effective Corrective Action and Preventative Action.
• Use risk management tools to drive reliable product quality and supply.
• Support Pre-Approval Inspection (PAI or equivalent experience) or other regulatory audits as a subject matter expert.
• Independently assess the impact of changes to products, processes, equipment, procedures, or materials.
• Lead cross-departmental teams to identify projects for improving yield, reducing costs, and enhancing efficiency.
• Perform and interpret complex data analysis, such as statistical process control and multivariate analysis.
• Assess operational safety by evaluating engineering controls and procedures.
• Review documentation like User Requirement Specifications and Process Flow Diagrams, and provide mentorship on engineering projects.
• Lead process performance qualification (PPQ) and continuous process verification (CPV) activities for commercial products.
• Support the development of start-up and commissioning plans with engineering and validation teams.
• Develop training curriculum for manufacturing operators.
• Facilitate timely conflict resolution as issues arise.

Key Requirements:

• Minimum of bachelor’s degree or equivalent experience required, preferably in Chemistry, Chemical Engineering, Biochemistry, or Biology.
• Proven experience with pharmaceutical research and manufacturing is required.
• Preferably experienced as the primary contact for multiple confidential clients.
• Experience in regulatory inspections and/or audits is an advantage.

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.