Associate Director, MSAT

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 impr...