The Associate Director of Formulation Development will support the drug product development function. Responsibilities will include leading, planning and managing the technical and business-related activities associated with drug product development and manufacturing of solid oral dosage forms at contract development sites.

Responsibilities:

• Use knowledge and experience to design and select appropriate formulations for toxicology and first in human studies
• Support formulation and process development, technology transfer and clinical manufacturing activities
• Develop strategies and execute plans for drug product development in accordance with timelines and requirements of overall development programs
• Select and manage contract development and manufacturing vendors
• Negotiate and approve statements of work and quotes
• Review and approve manufacturing documents, protocols and reports
• Work closely with other internal functional groups to ensure that all drug product requirements for clinical trials are met
• Work closely with QA to ensure clinical supplies meet quality requirements
• Prepare CMC sections of regulatory filings.
• 15-20% travel expected

Preferred Skills, Qualifications and Technical Proficiencies:

• Technical expertise in solid oral dose formulations for small molecules
• Must have hands-on experience in formulating drugs with limited solubility and is knowledgeable about technologies employed to enhance bioavailability
• Must have experience in formulation and process development from early to late phase development
• Solid understanding of ICH, FDA, EMA guidance in CMC and Quality areas
• Good working knowledge of GMP requirements for drug product development and manufacturing
• Experienced in writing CMC sections of regulatory filings
• Strong written and oral communication skills. Must be comfortable making presentations in team meetings and must have the ability to communicate complex technical information clearly and concisely
• Good project management and leadership skills, with ability to lead multiple programs at the same time
• Enjoy working in a fast-paced environment within a matrix organization

Preferred Education and Experience:

• PhD in Pharmaceutical Sciences or relevant technical field with 6-8 years experience or MS with 10 years experience.
• Minimum of 5 years in managing outsourced drug product development activities

The pay range that the Company reasonably expects to pay for this headquarters-based position is $181,000 - $213,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

Applicants must be currently authorized to work in the United States on a full-time basis.