Employment

Position Summary:

• Responsible for the development of the internal/external infrastructure to support all CMC development requirements
• Responsible for oversight all aspects of the manufacturing and release of drug substance and drug product
• Responsible for integration of clinical considerations in the development program plans that efficiently absorb risk in the advancement of therapeutic candidates

Location:

Boston Area

Functions:

• Provide direction in the evaluation and selection of New Molecular Entities in the formation of the portfolio
• Recruit and manage the CMC operations organization
• Develop processes governing manufacture of Drug Substance and Drug Product
• Manage project planning, budget, and resource deployment for manufacture of Drug Substance and Drug Product
• Identify, evaluate and ensure that outsourced vendors have the required expertise, capabilities, and quality/compliance standards to support API process development and supply and drug product formulation and supply. As necessary monitor activities of vendors
• Ensure scientific integrity and compliance with regulatory requirements for all CMC operations
• Ensure CMC plan aligns with business strategies
• Participate as an integral member of development team

Education:

PhD in a pharmaceutical sciences or an area of physical organic chemistry

Experience:

Minimum of eight years experience in CMC leadership of a pharmaceutical or biotech company

Skills:

• Expert knowledge of technical principles and concepts
• Strong leadership and management skills
• Excellent teamwork and collaboration skills
• Effective process and project management skills
• Outstanding written and verbal communication skills