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 establishing a strategic biomanufacturing base in China using GE Healthcare Solutions. With the new facility, Lonza is responding to growing demand for a high-quality CDMO in the Chinese market. The Cell banking group are responsible for the creation and maintenance of the Current Good Manufacture Practices master and working cell banks used for the production of novel therapeutic recombinant proteins for Lonza’s global client base.
• The role holder will eventually lead a team of 4 to 5 Full Time Employee and have a demonstrated track record and genuine interest in developing high performing individuals and teams.
• Owner of quality records (batch record, Standard Operation Procedure, Deviations, Corrective And Preventive Actions, change controls, tasks, effectiveness checks).
• Author and perform technical review of study data, protocols and reports to ensure delivery of high quality and Current Good Manufacture Practices compliant results.
• Document approval for all cell banking related documents including but not limited to batch records, Standard Operation Procedure, deviations.
• Reviews cell banking sections of regulatory submissions in order to ensure accuracy and compliance.
• Subject matter expert representing for all cell banking projects in customer audits, quality audits (internal and external) and regulatory audits
• Documentation of results in accordance with Lonza policies and current Good Manufacturing Practices
• Responsible for ensuring all batch review activities on all cell bank records are completed and available for cell bank release review on agreed schedule.
• Craft, align and execute the manufacturing functional strategy to deliver strategic business objectives in the cell banking area.
• Manage and deploy of resources (people/skill sets/equipment) to maintain agreed production schedules, control bottleneck process performance and resolve operational constraints to improve productivity.
• Maintain effective end-to-end process control mechanisms and performance metrics to deliver breakthrough performance in process control, safety, Current Good Manufacture Practices compliance, quality, cost and service
• Take a lead role in adherence to safety rules and regulations and proactively suggesting and leading areas of improvement
• To perform hands-on laboratory work as necessary to support cell banking activities.
• Activities include cell culture work (subculture, aseptic techniques), training, supervisor sign off of documentation, audits and off plant office based activities (document and report writing/review, leading quality meetings, writing quality documents, audit responses and leading investigations and improvements).
• Reviewing draft reports, proposals, presentations and scientific data to maintain the highest level of quality standards within the group
• Contributing to customer projects by generating, interpreting and/or reviewing scientific data from work performed by team or oneself, highlighting any atypical or unusual results and leading the investigation.
• Engage with customers as the face of the cell banking functional team to align customer needs with operational execution.
• Maintain sufficient technical / regulatory / business knowledge to represent the cell banking group internally on Customer project teams and externally at Customer visits, sales processes or any other associated activities
• Ensure and participate with the team to deliver high quality communication to provide an outstanding customer experience (written reports, presentations, teleconferences, face-to-face meetings).
• Ensure effective communication within peers, teams and departments locally and in Lonza’s global network.
• Collaborate with other departments locally and in Lonza’s global network to ensure consistency in technical approach and procedures
• Assess performance of direct reports and provide effective feedback, through appraisals and other feedback tools.
• Assess the present and future demand for employees with particular skills and develop recruitment plans to meet these needs.
• Foster a trusted and empowered environment through actively developing talent and establish a high performing team.
• Coach, mentor and train direct and indirect reports in the necessary scientific critique/knowledge and technical skills to achieve the department’s objectives and establish robust succession plans.
• Proactively suggest, execute and lead approved operational efficiency projects
• Take a lead role in day to day team management activities including but not limited to housekeeping, team meetings, equipment maintenance, management of cell banking inventory etc.
• Degree/ Doctor of Philosophy in a relevant Science field or Equivalent
• Work experience in relevant industry including people management experience
• Practical laboratory experience in Current Good Manufacture Practices cell banking activities is required
• Understanding of theory and application of recombinant protein expression
• The final role offered will be commensurate with the candidate’s experience.
• Understanding of Current Good Manufacture Practices regulations
• Excellent problem solving and analytical skills.
• Excellent communication skills (verbal and written).
• Excellent teamworking skills.
• Fluency in written and spoken English
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.