Associate Director, MSAT

at  Lonza

United States, Tampa (Florida)
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.
The Manufacturing Science and Technology (MSAT) Associate Director is accountable for the Lonza-Tampa commercial drug product portfolio throughout the product lifecycle and for technical operations within the GMP manufacturing operation. The MSAT Associate Director leads a team of scientists and engineers that use their expertise of the technology, operation, and regulatory requirements to ensure that processes are reliable and capable of delivering safe and high-quality products to patients.

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.
• Understands the requirements for commercialization of a product and leads the commercialization of products at the Lonza – Tampa site.
• Develop the manufacturing facility’s systems and capabilities to enable the product portfolio in clinical development.
• Designs and implements projects to build or modify systems for improvements in safety, quality or operational efficiency.
• Balance technical, operational, and regulatory requirements to implement strategic business initiatives within manufacturing operation.
• Develop colleagues within the MSAT team by providing leadership and mentorship to identify growth areas and growth plans for the team members.
• Provide leadership and manage interactions between the client and internal cross-functional project teams. Act as the project lead for commercial products guiding and overseeing the technical strategy for process validation and continuous improvements.
• Understand and apply chemical and engineering fundamentals including chemistry, materials science, heat and mass transfer, fluid mechanics, thermodynamics, conservation of mass and energy, and basic mathematical modeling.
• Leads process and/or technical-related investigations to support root cause analysis, product impact assessment, and effective Corrective Action and Preventative Action definition.
• Use risk management methodology and tools to drive reliable product quality and supply.
• Supports Pre-Approval Inspection (PAI) or other client and regulatory audits as product and process subject matter expert.
• Independently assesses impact of changes to the product, process, equipment, procedures or materials.
• Leads cross departmental teams to drive Operational Excellence by identifying projects to improve yield, lower costs, and improve efficiency.
• Performs or is able to understand and explain all types of complex data analysis, such as statistical process control, multiple linear regression analysis, ANOVA and multivariate analysis.
• Assess operational safety by evaluating engineering controls and procedures used in the manufacturing equipment and process.
• Reviews documentation such as User Requirement Specifications, Process Flow Diagrams, and Study Protocols. Develops process models and provides guidance on engineering projects.
• Lead process performance qualification (PPQ) and continuous process verification (CPV) activities for commercial products.
• Supports development of start-up and commissioning plans in conjunction with engineering and validation
• Support manufacturing team with development of training curriculum for operators.
• Facilitate timely conflict resolution as problems arise.

KEY REQUIREMENTS:

• Minimum of bachelor’s degree required with preference for Chemistry or Chemical Engineering, Biochemistry or Biology
• Experience with pharmaceutical research and manufacturing is required.
• Experience as primary contact for multiple confidential clients preferred.
• Experience in regulatory inspections and/or audits is preferred.
  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: R59477

Please refer the Job description for details