Associate Director/Director, CMC Operations, Pharmaceutical Development Job in Cambridge 02139, Massachusetts Us
Infinity is an innovative drug discovery and development company seeking to discover, develop and deliver to patients best-in-class medicines for difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. Infinity’s programs in the inhibition of the Hedgehog pathway, the Hsp90 chaperone system, PI3K and FAAH are evidence of its innovative approach to drug discovery and development. For more information on Infinity, please refer to the company’s website at www.infi.com.
Pharmaceutical Development’s focus is our products. By integrating the best practices in CMC, Pharmaceutical sciences, Analytical sciences, manufacturing, and supply, Pharm Dev provides innovative solutions and delivers high quality pharmaceutical products that enable the translation of Discovery breakthroughs into Clinical and Commercial success.
The Director of CMC Operations will be responsible for leading and directing CMC operations supporting our clinical development programs. The candidate must be a strong leader experienced in integrated approaches to CMC development, working with cross functional CMC teams in a matrix organization, have knowledge of global CMC development strategies and experience with late stage development and vendor management.
Responsibilities include:
- CMC development strategy and its integration into the overall strategic product development plans
- Lead, guide, and mentor CMC leaders and teams
- Maintain current, global knowledge of accepted and best CMC practices
- Positioning and preparing CMC activities for all Phases of development, including validation and NDA preparation
- Technology transfer and vendor management
- Work collaboratively with regulatory, quality, toxicology, clinical, chemistry, analytical, formulation, and supply functions to establish phase specific CMC practices for Infinity’s development programs
Experience and skills required:
- Ph.D. in Chemistry, Chemical Engineering, Analytical Chemistry, Pharmaceutical Sciences or equivalent with 10+ years experience in small molecule pharmaceutical development
- Extensive experience with CMC leadership and development
- Experience with late stage CMC development (Ph3/NDA/MAA) into commercialization
- Extensive knowledge of phase-specific, global CMC practices and regulatory requirements
- Experience with vendor management and technology transfer
- Demonstration of strong leadership and management abilities
- Excellent computer, documentation and organizational skills required
- Must have strong problem-solving skills and work ethic, good documentation and communication skills, as well as an attention to detail
- Ability to work in a cross-functional team environment is a must
- Title will be commensurate based on experience
To apply please visit our website: http://www.infi.com/careers-opportunities.asp