Regulatory Development Specialist
2 days ago
At Lonza, we are seeking an experienced Regulatory Development Specialist to lead the development, optimization, and troubleshooting of Biacore / SPR methods. This is a key role within our laboratory team, responsible for resolving challenging technical issues and delivering high-quality execution of experimental work following all safety and quality procedures.
- We are offering a highly competitive salary in the range of £80,000 - £110,000 per annum, depending on experience.
- The successful candidate will be responsible for planning and executing complex experiments, supporting more junior colleagues, and identifying and implementing technical and operational improvement projects.
- As a Lead Biacore Scientist, you will work closely with customers to resolve complex issues by understanding their needs, planning experimental work that meets customer expectations, presenting progress on project stages, and responding to customer questions.
- Competently plan and direct the work of others.
- Competently lead and be accountable for the delivery of multiple projects including creation and completion of project dashboards.
- Lead problem-solving, troubleshooting, and lessons learned activities.
- Coach, mentor, and train more junior members of the department as required.
- Role model for communication, best practice, and behavior within Development Services.
- Highly experienced in the field of Analytical Development.
- A high degree of proficiency in all of the following techniques: Biacore - SPR, ELISA/plate based methods, cell-based methods.
- Experience in the implementation of high-throughput automated methods and digitisation of processes would be an advantage.
- Additionally, understanding of regulatory requirements, CMC, and experience in DOE/AQbD would be an advantage.
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