Job Details
Manufacturing Manager
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 is building a large-scale dedicated facility to allogenic product for a key customer. The Manufacturing Manager will initially participate in defining and reviewing the user requirement for the new drug product facility for Cell Therapy product. During process -fit out phase of the project, Manufacturing manager is responsible for supporting the construction, commissioning and validation of the new facility. Upon completion of the facility Manufacturing manager is responsible for managing the overall production readiness, execution, and batch delivery for the production Cell Therapy product under cGMP conditions. Manufacturing Managers will provide an immediate response to issues during manufacturing batch production. Managers will be responsible for leading cross-functional teams and customers to determine a clear understanding of problems and solutions. The Manufacturing Manager is the technical point of contact for support group questions regarding production execution, and owner of the equipment in the suite, including change control assessments for equipment modifications or new equipment, owner/approver of manufacturing relevant deviations and CAPAs ownership. Managers review/approve automation updates, validation, and maintenance protocols and the primary point of contact for these changes. Manufacturing Managers manage suite readiness planners and expert trainers and provide coaching/mentoring to manufacturing supervisors and associates.
(Key Accountabilities)
- Deliver to Ready, Run, Release priorities per Plan. Independently able to make decisions and run the suites. Must reduce the variability of duration/time between runs related to equipment, process or document issue
- Proficient in Root Cause Analysis / Cause Mapping to ensure effective proactive identification to prevent issues or problem resolution from eliminating the recurrence of the problems Identification and implementation of preventative actions in response to safety near misses or incidents Equipment Cost Center Review for all areas of responsibility. Runs major investigations and develops Storyboards as needed, e.g., contamination, etc.
- Process Management. Create and maintain a process-specific reference guide for troubleshooting, response, and escalation. Accountable for SOP clarity, accuracy, and relevance. Responsible for organizing SOPs for most efficient & effective ownership by supervisors and operators. Ensure owners have the expertise required to own the SOPs. Follow up on DMS suite board actions/escalations as related to Equipment, Documents or Process
- Equipment and Process SME: Identify non-routine technical training associates may need, develop material via Expert trainer, or supervisors/associates. SME for analytical instruments, e.g., FIT, NOVA, Density Meters, Vicell, etc. Develop associate SMEs for these technologies. Conduct Post Campaign MFG Lessons Learned, which includes eDCF Review w MSAT (Face to Face).
- Addresses Regulatory and Customer Audit Requests and any observation responses for Documents, Equipment, and Process. Participate in inspections as Backroom Triage Manufacturing Representative.
- Actively provide coaching and mentoring to supervisors, associates by involving employees in issue identification and resolution.
- Perform other duties as assigned.
Key Requirements:- BS degree or higher in a Life Sciences, Engineering or Management or related science discipline
- Minimum 10 years of experience in GMP manufacturing of products regulated by FDA CBER or CDER or EMA
- Minimum of 7 years of experience in leadership positions
- Must have prior aseptic processing experience
- Highly preferable to have drug product and /or combination product manufacturing experience
- Proven experience implementing CI initiatives to drive manufacturing improvements.
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