Viral Vector Manufacturing Project Specialist
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 Project Specialist is responsible to lead manufacturing projects in partnership with the Manufacturing Leadership Team. This person will work closely with Manufacturing Management to support the achievement of department goals, technology transfers, interdepartmental readiness and batch release requirements. The Senior Manufacturing Project Specialist is the Subject Matter Expert (SME) for their area and general business processes. This person is key contributor to technology transfer and all activities directly support campaign readiness. The Senior Project Specialist can effectively represent his functional area on site initiatives and capable interfacing with Lonza customers.
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.
Manage and monitor: Technology transfers, campaign support and readiness, capital projects,
Process specific change controls, Corrective and Prevention Action (CAPA’s), Laboratory Investigation Reports (LIR), Validation activities.
Drive and own improvement internal and cross-functional projects that support department Key Performance Indictor (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
Associate or Bachelor Degree in Biology, Chemistry, or Engineering
Extensive Biotechnology experience preferably Upstream and Downstream, or similar Manufacturing industry.
Advanced technical knowledge of manufacturing operations (ideally all areas of manufacturing, but strong in some areas and ability to quickly learn other areas is acceptable).
Working knowledge and experience with Quality Systems including deviations, change controls, CAPAs, 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.
Process transfers and campaign readiness experience
Demonstrated ability to manage medium to large sized projects within required timeframes.
Demonstrate ability for effective Planning, Organizing and Controlling competency
Demonstrate sound decision making, considering broad scope of factors
Ability to work inter-departmentally and with customers.
Demonstrates role model behaviors for GMP and Safety behaviors
Experience in various Operational Excellence tools such as Root Cause Analysis, Failure Modes and Effects Analysis, Value Stream Mapping etc.
Strong written and verbal communication skills
Ability to work in MS Project, Word, Excel, PowerPoint
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.