MSAT Manager (Personalized Medicine)
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.
Lonza in Kingston, ON has an exciting opening for an MSAT Manager to join our Personalized Medicine business unit. The MSAT Manager will be responsible for ensuring that operational, quality and regulatory requirements are effectively established and maintained. Key area of focus is related to the leadership of technical transfers from design and development, Process Development to Manufacturing as well as supporting Cocoon® Platform technology transfer to Clients.
- Supply appropriate coaching and a feedback on performances to direct reports and assures the development of all team members.
- Data Monitoring & Collection - Data driven decision making:
- timely review and analysis of process data to ensure process performance
Process optimization and improvement:
- Responsible for continuous process improvement, which includes proposal of process modifications in order to improve robustness, productivity and overall process performance. These process improvements are generally derived from continuous monitoring and data analysis.
- Execution of assigned tasks and responsibilities during process validations. These responsibilities include generation, review of applicable process validation protocols and reports, data collection and analysis, as well as update of the Validation Master Plan.
On floor support:
- Provision of technical assistance to Manufacturing for critical operations that require specific knowledge going beyond routine manufacturing operations (e.g. new processes, new procedures).
- With the team, serves as SMEs for leading or assisting in conventional investigations.
- Act as a leader for investigation of more complex investigations.
Change requests / Change controls Assessment:
- Responsible for the assessment of Change requests or Change controls with potential process/product Quality impact.
- Might act (as required) as reviewer of Engineering protocols for equipment commissioning which require MSAT expertise for proper design and execution. This reviewer role is also applicable to equipment functional specifications created by Engineering.
Tech transfers & new projects:
- Collaboration in tech transfer projects for new products- active role in the multidisciplinary team involved in the transfer process (Engineering, Manufacturing, etc.).
- Maintains Device History File, Device Master Record and technical transfer documentation to support Drug Master File, Technical files, conformity assessment files, and country specific files.
- Technical contact for development of projects with R&D and Process Development
- Bachelor’s degree in Engineering or Science; Master’s degree preferred
- Project Management Certification; Quality Certification (ASQ); Lean Six Sigma Black Belt are a plus
- Significant experience in Process Controls, Validation, Design Transfer in Medical Device (ISO 13485.2016)
- Thorough knowledge of cGMP/GLP/ISO 13485/US FDA 21 CFR 820/EU Directives/ICH9/ICH 10/ATMP
- Significant experience in a Technical leadership role
- Project Management experience
- Leadership qualities that facilitate efficient and effective collaboration towards Corporate and Business Unit goals
- Minimum 5-year management experience in a related regulated industry
- Strong computer skills and proficiency in written and verbal communication
- Experience with validation/qualification and database systems
- Ability to problem solve and troubleshoot
- Must be able to work in a team environment with exceptional interpersonal skills
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.