Senior Scientist - Analytical Development & Method Validation
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.
You will be joining the Analytical Development team within Clinical Development in Lonza Singapore, focusing on test method validation, development and life cycle management. 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 lead and execute studies on the development and validation of purity, impurity, identity or charged isoform analytical methods and to provide technical expertise to support troubleshooting activities at both laboratory and manufacturing scale to a high standard in compliance with ICH guidelines, GMP and business principles.
- Author, review and perform technical review of study protocols and reports, ensuring delivery of high quality and GMP compliant data.
- Lead and direct study programmes at a senior level including the execution of associated laboratory work
- Projects require the delivery of analytical method validation or development work packages for antibodies and other therapeutic recombinant proteins.
- Test methods include, but are not limited to, techniques using capillary electrophoresis, HPLC, spectrophotometry, ELISAs, etc.
- Maintenance of test method life cycles, analytical equipment, and related technologies and/or systems.
- Contribute to process validation / characterisation activities by performing supporting laboratory scale studies.
- Contribute to customer projects by generating and interpreting scientific data from experimental work.
- Technical review of data generated by others highlighting any unusual or atypical results and leading appropriate investigations.
- Deliver high quality communication to ensure an outstanding customer experience (written reports, teleconferences and face to face meetings).
- Coach, train and mentor junior members of the team to assist in their development, providing a transfer of knowledge and hands-on technical training.
- In capacity as a method SME and/or platform owner, represent Lonza in discussions with the customer about specific study results in support of project team as well as supporting customer and regulatory audits where required.
- Working as part of a site and global project team, co-ordinate multiple projects and ensure timely delivery of project work stages. Supervision of small project teams also be required.
- Lead atypical/OOS investigations within the laboratory.
- Facilitate communication between other departments in Singapore (eg QC/QA) and across the global Lonza network.
- Manage assay transfers across laboratories and sites when necessary.
- Owner of quality records (Deviations, CAPAs, change controls, tasks, effectiveness checks).
- Experience working within a formal Quality Management System (such as cGMP)
- Degree/PhD in a relevant Science field or Equivalent
- Minimum 5 years work experience or PhD with 2 years’ postdoctoral experience
- Practical laboratory experience in analytical testing for antibodies or proteins is required although training will be provided
- Understanding of theory and application of protein production and purification
- Good problem solving and analytical skills
- Good communication skills (verbal and written)
- Good team working skills
- Good understanding and application of cGMP concepts.
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.