Job Description
Senior Specialist in Analytical Science: The position provides technical input to teams, coaching associate staff, and leading analytical method and PAT SME. Key responsibilities include experimental design, data analysis, and development of assays. Technical leadership is required for manufacturing science and technology initiatives. The role involves authoring and reviewing documents, technical lead for characterization testing, and supporting multidisciplinary teams.
- **Leadership and Change Management**: Demonstrated leadership and change management skills with a focus on continuous improvement.
- **Analytical Experience**: Experience with analytical testing in support of upstream cell culture and downstream purification of biological molecules, analytical chromatography, and mass spectrometry.
- **Regulatory Knowledge**: Working knowledge of current regulatory requirements and current Good Manufacturing Practices.
- **Education**: Bachelor's degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry, with a proven track record in delivering excellence.
- **Prior Experience**: A minimum of 6 years' experience (for MSc), 8 years' experience (for BSc) in academia, pharmaceutical or biotechnology company, with experience in drug substance process development, process characterization studies, and regulatory filing.