Manufacturing Process Expert- DP
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.
As Manufacturing Process Expert DP, you will manage the operational activities of assigned Drug Product manufacturing projects in the new sterile Drug Product Manufacturing facility in Ibex. Overall responsibility of manufacturing execution with regard to safety, quality and on-time-in full delivery as well as full compliance with regulatory requirements, GMP/SHE regulations, Lonza policies, procedures and standards. Functional lead for an interdisciplinary team of production leaders, supervisors and specialists. Is accountable for the performance and results of the assigned projects
- Responsible for the planning, the execution and documentation of manufacturing campaigns for Drug Product in compliance to cGMPs, SOPs and applicable guidelines. Securing each batch is manufactured safely, on time, in compliance with the batch instructions and quality requirements
- Provides front line technical and procedural support, working with the manufacturing teams (operators), plant engineers and QA operations.
- Responsible to establish timely and with high quality the required production documentation (preparation and review of electronic batch records) or other relevant GMP documents for the assigned production area.
- Lead process related investigations and critical deviations and assists in decision making on production issues
- Lead process changes, CAPAs, and CAPA effectiveness checks related to process within required timelines and through GMP systems (e.g. Trackwise, MES, training, etc.)
- Supports the execution of process validations, including planning and preparation of the required validation plans and reports, liaising with all the relevant parties at shopfloor to ensure accurate execution
- Use scientific, process and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures
- Be highly knowledgeable of product and process trends by providing input to Annual Product Reviews and Product Quality Review for analysis
- Be a resource to other departments as Subject Matter Expert for the product and process knowledge
- Provide training for assigned new processes and products
- Acts as Subject Matter Expert during customer audits and visits, maintain their processes at inspection readiness level and to provide the necessary support
- Responsible to prepare and execute SHE, EM and operation risk analysis for the assigned products and the implementation and control of defined measures.
- Executes innovation and improvement projects comprising general manufacturing aspects for the production plant.
- Bachelor or above, majoring in Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
- Extensive working experience in Sterile Manufacturing on the shopfloor and/or QC/QA related area;
- Proven process understanding in Sterile Manufacturing (Pharma, regulatory aspects)
- Familiarity with GMP requirements, quality procedures and SOP execution
- Good communication skills and interaction with a variety of interfaces within the organization and on the shopfloor
- Strong team orientation
- Structured and proactive working attitude
- Self-driven and result-oriented.
- Proven IT knowledge, knowledge in ERFP (SAP) or MES (Syncade) is an asset
- Prepared to work flexible working hours
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.