POSITION: CMC Analytical Development Scientist
REPORTS TO: Director CMC Analytical Development
Analytical Development support to Crescendos portfolio, including internal analytical testing and support of outsourced analytical activities (at CROs/CDMOs).
- Develop and utilise novel analytical techniques to support lead-candidate developability, protein characterisation, and identification of potential Critical Quality tributes (pCQAs) for Crescendos Humabody Development pipeline.
- Independently and proactively support in-process testing, product quality analysis and forced degradation studies (determining mechanisms of degradation or protein-protein interactions as required).
- Represent the CMC Analytical Development function as a Subject Matter Expert (SME) on internal & external project teams.
- Lead, coach and mentor the internal scientific teams engaged in analytical support, to facilitate product candidate molecule development.
- Produce and maintain CMC Analytical Development records, SOPs and documentation to support regulatory submissions and inspections.
- Maintain awareness of, and ensure compliance with, Crescendos policies and cGMP procedures relating to outsourced cGMP manufacture.
- Support CMC pre-formulation development and stability evaluation.
- Design & execute Clinical compatibility studies.
Education and Experience
• PhD or equivalent
• Relevant industry experience of biotherapeutics analytical development and characterisation across multiple technology platforms (including chromatography, electrophoresis, biophysical and MS characterisation).
Skills and Knowledge
• Extensive experience of protein analytical/physicochemical strategies and characterisation of complex biological products e.g. antibody/bi-specifics
• Strong communication skills, with the ability to build strong relationships with key individuals at CMC suppliers and interact effectively in multidisciplinary teams both internally and externally.
• Highly organised with excellent attention to detail, able to prioritise work, works well under
pressure to meet deadlines.
• Excellent documentation and report writing.
• Ability to effectively co-ordinate the activity of colleagues within the functional team, and
to communicate effectively with external advisors and senior managers.
Please send a covering letter together with your CV to email@example.com