Company Overview:
We’re partnering with a leading CDMO, that are committed to pushing the boundaries of science to discover and develop cutting-edge solutions for unmet medical needs. As they expand their research and development efforts, we are seeking a highly skilled and motivated Senior Scientist with expertise in Analytical Development to join their dynamic team.
Position Overview:
We are looking for a Senior Scientist with a strong background in Analytical Development to contribute to the advancement of their drug-development capabilities from pre-clinical to late phase and commercial manufacture. The successful candidate will play a key role in designing, developing and validating analytical methods for the characterization and quality control of biopharmaceutical products.
Responsibilities:
- Lead analytical aspects of a project as directed and provide analytical updates during internal and external project meetings as required
- Support and supervise analytical and development employees in analytical project-based activities, providing leadership and technical support in laboratory activities
- Ensure accurate completion of analytical records relating to both R&D and QC activities, including supporting documentation such as SOPs and risk assessments
- Contribute to writing and reviewing analytical methods, protocols and reports as directed
- Conduct and supervise analytical method set up, development and qualification/validation activities
- Support the leadership team in ensuring R&D and QC analytical equipment and laboratory processes are maintained as fit-for-purpose, to meet customer requirements and support the scope of activities
Qualifications and experience:
- Extensive experience in Hi-Performance Liquid Chromatography and experience in method development and/or method validation
- Desired experience in Gas chromatography, HPLC-Mass spectroscopy, Dissolution, Karl Fisher
- Ability to use own initiative and anticipate teams needs
- Able to take ownership and lead on projects
- Able to organise and manage workflow and activity to meet business critical budgets and timelines
- Proficient in word and excel
- Able to present data at internal and external meetings to various audiences