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 Cytiva (Formally GE Healthcare Solutions). With the new facility, Lonza is responding to growing demand for a high-quality CDMO in the Chinese market. The two companies will work closely on the design of the 17,000 m2 site, which will include 6,500 m2 of lab space and one KUBio facility. With more than 20 successful FDA approvals for biologics, combined with international regulatory expertise, Lonza will now be able to offer the same high standards in China as it does elsewhere. Lonza plans to hire and train a significant number of staff for this site.
- Design and develop new paper record Master Batch Record (MBR), using existing MBR templates, in support of Technology Transfers
- Design and develop new Electronic Batch Record (eBR), utilizing the knowledge of know how to create, test and launch eBR in the system for execution
- Maintain currency of MBRs/eBRs for existing customers
- Write and edit technical information/ instructions in a manner to ensure content is factual and accurate
- Collaborate closely with relevant SMEs from various disciplines on documentation requirements
- Manage the lifecycle of MBRs/eBRs including, but not limited to creation, review, revision and approval of MBRs/eBRs on product campaign basis
- Communicate actively to address customers’ comments and to clarify customers’ queries with respect to MBRs/eBR
- Deliver MBRs/eBRs with strict adherence to the production schedule
- Provide assessments and insights to Change Requests from TWT’s perspective
- Perform detailed and thorough investigation for deviations, non-conformities and/ or abnormalities which occur on production floors
- Involve in the deviation investigation, batch record review and TrackWise documentation. Possess TrackWise Supervisory access
- Ensure timely investigation and closure of all deviation reports in support of lot disposition.
- The completion of a deviation report includes but not limited to root cause analysis utilizing standard methodologies e.g. 5-Whys, Ishigawa Diagrams, Failure Mode, Effect and Cause Analysis (FMECA), product/ quality impact assessment/ justification and design of appropriate CAPA(s) with effectiveness checks, where required
- Lead investigation by facilitating discussions with relevant SMEs from all departments in the course of deviation investigation
- Coordinate and collaborate cross-functionally to achieve completion of an investigation and the design of appropriate CAPA(s)
- Interact with customers in the form of face-to-face meetings and/ or teleconferences to communicate investigation findings/ outcomes to the customer
- Present the output from an investigation in the form of a deviation report and ensure the information populated in the deviation report, in particular the most probable root cause, impacted and associated lots is factual and accurate
- Prepare and own storyboards for identified deviations to facilitate customer and regulatory audits
- Participate in customer and regulatory audits to present and walk auditors through the deviation investigation
- Involve in preparation of deviation metrics, to identify trends and work with Lead/ Manager to put in place measures to improve deviation life cycle, deviations reduction and any other areas of improvement
- Provide continued motivational and team building atmosphere. Assist Manufacturing management in the definition, development and provision of career progression paths for individuals
- Carry out performance reviews and recommend advancements for team members where reasonable
- Responsible for staffing, training and retaining energized, motivated, team oriented staffs
- Responsible for continuous learning, development and advancement of staffs
- Assume accountability on recognition and disciplinary responsibility for all team members
- Any other duties as assigned by your Supervisor/Manager
- BS in Engineering (Chemical/ Biochemical) or Science (Biochemistry/ Chemistry/ Microbiology) related disciplines preferred
- Work experience in a cGMP regulated environment and prior technical knowledge in biopharmaceutical processing will be an advantage
- Strong technical communication and writing skills
- Excellent oral presentation skills
- Exhibit strong command of English and Chinese both in writing and oral.
- Effective interaction skills with MSAT, MFG, QA, VAL, QC, ENG, customers and auditors
- Strong proficiency in standard Microsoft Office applications e.g. MS Word and MS PowerPoint
- Track record in completing projects under tight timelines
- Ability to quickly grasp and translate complex technical concepts to comprehensible instructional texts
- Ability to influence peers and teams with no direct reporting lines
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.