Cell Therapy Manufacturing Project Lead
Cell Therapy Manufacturing Project Lead
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 Houston's Cell and Gene Therapy Facility is the largest in the world and is still growing. The Manufacturing Project Specialist will work with our Cell Therapy group and is responsible for leading and driving cross functional manufacturing projects in partnership with the Manufacturing Leadership Team to completion.
The individual will manage and execute a collection of projects in addition to ensuring Manufacturing CAPA closures, Change Controls, LIRs, OTN and site deviations.
The Manufacturing Project Lead has responsibility for the planning, preparation, implementation and delivery of projects assigned.
The individual works cross-functionally and in collaboration with internal support departments, customers and Manufacturing suites to develop or update internal policies, procedures or steps, identifies and escalate risks, communicates changes and plan for execution.
The Project Specialist is responsible for owning and driving manufacturing improvement projects from concept to completion, with a particular focus on creating efficiencies that contribute to quality, cost, on-time delivery and right first time performance.
This role may include the mentoring, management and oversight of other manufacturing Project Associates, specialists and temp labor.
Own, manage, and monitor functional area projects and tasks: Technology transfers, capital projects, campaign support and readiness, MFG process specific change controls, CAPA’s, Laboratory Investigation Reports (LIR), Validation activities.
Drive and own improvement internal and cross-functional projects that support department KPI’s, with a focus on cost, innovation, on-time delivery and quality. Manage projects from concept to completion; create and manage project plan, work cross-functionally to ensure right first time and provide adequate training to impacted areas.
Mentoring individuals or teams, managing the temporary labor
Bachelor’s Degree in Life Science preferred.
Advanced technical knowledge of cell therapy manufacturing operations/ process (ideally all areas of manufacturing, but strong in some areas and ability to quickly learn other areas is acceptable). Thorough knowledge and understanding of batch records procedures, and other documentation required for manufacturing execution.
Direct experience with Cell Therapy equipment such as LOVO, Sepax, CliniMACS, Prodigy, etc required.
Working knowledge and experience with Quality Systems including deviations, change controls, OTNs, deviations; both the system (TrackWise) and the practical applications in operations.
Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment.
Experience in various Operational Excellence tools such as Root Cause Analysis, Failure Modes and Effects Analysis, Value Stream Mapping, Kaizen, Statistical Process Control, SMED etc. preferred.
Advanced experience in process transfer readiness procedures.
Excellent communication skills both verbal and written.
PMP, Lean Six Sigma Green or Black belt certification nice to have, but not required.
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.