CMC Analytical Development

REPORTS TO:
SVP CMC & Development

JOB PURPOSE:
Manage Analytical Development team to support Crescendos portfolio, including internal analytics and management of outsourced analytical activities at CROs/CDMOs).

KEY RESPONSIBILITIES:

- Represent CMC Analytical Development function as Subject Matter Expert (SME) on internal & external project teams.
- Responsible for Technology transfer of analytical packages to CDMOs
- Define GMP release, stability and characterisation specifications
- Review and approval of CDMO protocols, specifications and reports
- Management of DS & DP stability studies and shelflife management strategy
- Develop analytical technologies and create SOPs for in-process testing and product quality analysis for Crescendos Humabody pipeline.
- Lead, coach and mentor the internal scientific teams engaged in analytical and formulation development, to support product candidate development.
- Produce and maintain CMC Analytical Development records and documentation to support regulatory submissions and inspections.
- To communicate progress and identify risks and issues arising to the SVP CMC as appropriate.
- Definition and monitoring of potential critical quality attributes (pCQAs) for Crescendos Development molecules
- CMC pre-formulation development and stability evaluation
- Management of Analytical Developability packages for pre-CN projects
- Design & execution of Clinical compatibility studies

JOB REQUIREMENTS:

Education and Experience
• PhD or equivalent
• Relevant industry experience with protein/antibody analytical & formulation development.

Skills and Knowledge
• Extensive knowledge of CMC analytics and formulation development including troubleshooting skills in these areas.
• Able to build strong relationships with key individuals at CMC suppliers and interact effectively in multidisciplinary teams both internally and externally.

Competencies
• 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.
• To maintain awareness of and ensure compliance with Crescendos policies and cGMP procedures relating to outsourced cGMP manufacture.