Description:  This is a senior position within the CMC Group at Concert.  The Associate Director – Pharmaceutics will be responsible for the strategy, operation and scientific leadership of all dosage form design activities.  The Associate Director will integrate their skills and knowledge of pharmaceutics to support pre-development and development work.  In addition, they will identify and manage outsourcing partners and ensure delivery of CMC goals.

Responsibilities:

• Leadership of pharmaceutics activities within the CMC team. 
• Ensure successful development and manufacture of drug product and supporting CMC activities for early and mid-stage small-molecule drug candidates
• Manage outsourcing and consulting activities
• Propose and actively manage departmental budgets for dosage form development
• Produce high-quality documentation in support of  regulatory filings
• Manage a subordinates as necessary

Qualifications:

• PhD in pharmaceutics
• 8+ years experience of dosage form development and cGMP manufacture, either in-house or outsourced
• Experience in project management
• Extensive man-management skills
• Experience of modified-release formulation development
• Demonstrated leadership and technical proficiency in novel formulation approaches is especially advantageous
• Extensive knowledge of ICH guidance and CMC-related regulatory requirements

Contact Us:  To learn more about this position or to apply, please contact us at careers@concertpharma.com.

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