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 bio manufacturing 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. You are responsible for all operational and administrative activities which occur within the individual's team. Operationally, this includes the precise execution of manufacturing operations, strict adherence to production schedule, timely delivery of Master Batch Records (MBRs) and closure of Deviations, CAPAs etc. In addition, you are expected to define, monitor and drive metrics for measuring performance effectiveness of the group against the site's Key Performance Indicators (KPls): Safety, Quality, Delivery, Costs, Innovation and People. Administratively, you are responsible for the development of resource/ budget plans, maintenance of cost centers and appropriate staffing levels. You will report to the Head of Manufacturing.
- Provide a safe, controlled work environment in all areas of responsibility. Be aware of the site safety objectives and make sure they are communicated and understood by all staff.
- Responsibilities include staffing, training and retaining energized, motivated, team oriented staff. Will need to stress and carry forward operator training, education and advancement. Utilize work staff in an efficient manner through cross training and flexible resource planning.
- Work with Quality groups to ensure cGMP compliance in all areas of manufacturing. Endeavor to have all batch records real time reviewed in support of on time lot release. Accept accountability for variance and deviation generation rates and ensure their timely closure.
- Work with Tech Transfer teams to bring on and maintain customers' processes. Collaborate with the MSAT group to bring process improvements to routine manufacturing.
- Participate in annual budgeting and be responsible for meeting financial goals and objectives. Attempt to identify and contribute to real operational improvements and philosophy.
- Will be held responsible for meeting production schedules yield targets. Will be challenged to help create a continuously improving manufacturing operation that excels both technically and operationally. Help develop and manage information systems to monitor the efficiency and success of the operation.
- Responsible for coordinating required facility improvement projects with production requirements.
- Review and adjust personnel experience to meet demands of changing production requirements. Have a 4-8 month forward look on production demands to responds accordingly.
- Communicate actively site's safety/ quality objectives and ensure thorough cascade through reporting lines
- Pursue Continuous Improvement(Cl) programs and practice Leaders' Standard Work (LSW)
- Monitor/ review performance of staff and organize necessary interventions for developments/ improvements
- Inculcate and enforce a strong quality mindset via tracking programs and GEMBA sessions
- Analyze quality attributes for early detection of adverse trends and devise countermeasures for recovery
- Provide supervision over deviation investigation and MBRs creation/revision
- Manage Deviations/ MBRs lifecycles to ensure timely closure deviations and on-time delivery of MBRs
- Review deviation reports/ MBRs to ensure consistency and high standards in technical investigation and writing
- Partner with Quality Assurance (QA) group to enforce CGMP compliance in all aspects of manufacturing
- Possess functional knowledge of local statutory standards/requirements with respect to safety (e. g. WSH guidelines) and workplace practices (e. g. MOM guidelines)
- Collaborate with Human Resource Business Partner(HRBP)in the determination of human resources required, staffing and retention
- Drive Manufacturing Sciences and Technology (MSAT) and Supply Chain Management (SCM) departments in defining the material resources required
- Manage human and material resources to meet production targets
- Implement, control, review and adjust(when required)the production schedule
- Make decisions with respect to asset utilization, maintenance, modification and procurement
- Create developmental plans for high-potentials to ensure continuous learning and advancement
- Demonstrate strong knowledge in manufacturing processes and technical workflows e.g. deviation management, MBRs lifecycle management
- Participate in annual budgeting, maintain and manage cost centers to meet financial goals and objectives. Remove obstacles to deviation closures and MBRs approvals by working closely with both internal and external stakeholders Identify, develop and optimize workflows for operational improvements and efficiencies
- Collaborate with Manufacturing Sciences and Technology (MSAT) group to ensure robustness/improvements to routine manufacturing as well as technology transfers
- Develop succession plans for key roles within individual's group
- Spearhead cost control/ efficiency programs/ projects
- Develop flexible resource plan to maximize productivity and efficiency of the teams
- Steer high-level cross-departmental work groups and provide directions to ensure efficient collaboration and alignment to Manufacturing needs
- Resolve/ manage timeline/ resource constraints and conflicts via appropriate prioritization and escalation
- Work with Program Management(PM) group to facilitate customers' meetings and lot releases
- Any other tasks as and when assigned by the superior
- Bachelor Degree in Science/Engineering discipline
- Significant experience in Production/Quality/Validation function in biopharma manufacturing industry
- Excellent communication skill in English and Mandarin
- Familiarity with Regulatory requirements and local Codes & Standards (e. g. , FDA, EMEA, GAMP and ICHQ7)
- Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility
- Good leadership skills
- Strong interpersonal skills
- Effective Communicator (oral and written)
- Exhibit good quality decision making traits
- Meticulous and Systematic
- Analytical Mind
- Ability to define specific goals clearly, to develop and prioritize activities
- Team player, with strong focus on safety, quality and timelines
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.