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 successful applicant for this position will be joining the Analytical Development team within Clinical Development in Lonza Guangzhou, China. The Clinical Development group is responsible for the development and characterization of manufacturing processes used for the production of novel therapeutic recombinant proteins for Lonza’s global client base. The purpose of this role is to execute analytical activities to a high standard in compliance with ICH guidelines, GMP and business principles. The analytical team provide analytical testing to support process development teams as well as conduct cGMP activities in the areas of analytical method development, validation and stability testing.
- To perform hands-on laboratory work in the analytical development team to support process development teams to generate test data to enable cell line selection, upstream process development and purification process development.
- To perform hands-on laboratory work to support protein structure / function determination. These can include protein characterisation, product stability testing, test method development and assay validation activities.
- Responsible for test methods include GP HPLC, PrA HPLC, CEX, Glycan analysis techniques. And capillary electrophoresis, ELISAs, qPCR methods are also in work scope for long-term.
- General laboratory support including housekeeping, equipment calibration and maintenance, inventory of supplies, etc.
- Contribute to customer projects by generating and interpreting scientific data from experimental work.
- Deliver high quality communication to ensure an outstanding customer experience (written reports, presentations, teleconferences and face to face meetings).
- Working as part of a site and global project team, co-ordinate (if at a senior level) multiple projects and ensure timely delivery of project work stages.
- Facilitate communication between other departments locally (eg QC/QA) and across the global Lonza network.
- Documentation of results in accordance with Lonza policies and current Good Manufacturing Practices (cGMP).
- Technical review of data generated by others highlighting any unusual or atypical results and leading appropriate investigations (eg OOS).
- Mentor junior members to assist in their development, providing a transfer of knowledge and hands-on technical training.
- Be owner of quality records ((Deviations, CAPAs, change controls, tasks, effectiveness checks).
- Lead and direct study programs including the execution of associated laboratory work once candidate gains sufficient experience in Lonza
- If at a senior level, author and perform technical review of study data, protocols and reports to ensure delivery of high quality and GMP compliant results.
- The initial phase of this position will be involved in the establishment of the facility (including but not limited to equipment and inventory purchase, equipment qualification runs, facility design and set up).
- Degree in a relevant Science field or Equivalent
- Practical work experience or PhD with minimum 2 years of postdoctoral experience
- Practical laboratory experience in analytical testing for antibodies or proteins is required
- Understanding of theory and application of protein production, purification and analysis
- Good problem solving and analytical skills
- Good communication skills (verbal and written)
- Good team working skills
- Experience working within a formal Quality Management System (cGxP/ISO)
- Fluency in written and spoken English will be advantageous
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.