The Manager/Director of Manufacturing and CMC has primary management responsibility for overseeing the development efforts regarding API, drug product production, and the CMC regulatory issues necessary to enable the Research groups mission of developing new therapeutics and transitioning its development stage compounds into clinical development.  This person is also a key scientific advisor of the drug discovery team across PGxHealth Research comprised of pharmacology, chemistry, toxicology, clinical development and regulatory group leaders.  This person will coordinate activities at external laboratories and manufacturers and work closely with the company’s internal scientific team.  

• Support of new drug formulation development, manufacturing scale up process, preclinical and clinical development.
• Development and execution of stability, validation and analytical method transfer protocols.
• Support of lead optimization process and preclinical development.
• Support of formulation development for new drug products.
• Characterization of reference standards.
• Development, optimization and validation of analytical methods.
• Participating in a filing process of an Investigational New Drug Application (IND) to the FDA.
• Member of company’s Product Development Group which determines scientific strategy for the company’s discovery and develoment programs 

Education

• A minimum of a Bachelor's degree (B. A.) preferably in organic or analytical chemistry, biochemistry or pharmacy from four-year college or university.
• Preference for applicants with advanced degrees or training. 

Experience

5+ years experience in research and development or in a regulatory role

Knowledge, Skills and Abilities (language, technical, communication, etc.)

• Firm knowledge of applicable regulations for submitting CMC content for INDs and NDAs and/ or BLAs
• Experience in maintaining CMC sections and in assuring the related regulatory compliance of ongoing manufacturing and testing.
• Capable to participate in and/or lead multi-disciplinary teams to the successful and timely closure of CMC submission goals
• Hands-on experience with assuring GMP compliance in a development and / or commercial laboratory and manufacturing environment
• Experience in managing relationships with contract manufacturers and test laboratories
• Excellent communication skills (oral and written) 

Office, Charlottesville, VA - Maybe New Haven, CT.

Some travel to will be required to coordinate activities across PGxHealth Research as well as to support other collaborations or business relationships.