Associate Director of Small-Molecule Formulation Development and Drug Product Manufacturing
This newly created position will report to the VP of Preclinical Development & SM CMC.
The Associate Director of SM Formulation Development & DP Manufacturing will be a key member of the internal CMC Team and will support the early clinical evaluation of the company’s experimental therapies. She/He will collaborate with the rest of the CMC Team and a group of external expert consultants to identify appropriate formulations to support the early development of the company’s products. She/He will initiate, evaluate, and negotiate contracts and manage CROs for formulation development and Drug Product GMP manufacture. She/He will oversee the development and validation of analytical methods and assume responsibility for multiple long-term stability studies for Drug Product. She/He will collaborate with Quality Assurance to ensure the quality of the company’s manufactured products. She/He will participate in the generation and finalization of technical reports and regulatory documents in the areas of responsibility.
Minimum requirements include a Ph.D. in pharmaceutical sciences or a Pharm.D. degree, at least 10 years of work experience in a high-quality industry environment, and experience in managing various types of CROs in support of small-molecule formulation development / DP manufacturing activities. Alternatively, the candidate will have acquired the relevant work experience by working at a relevant high-quality CRO. She/He must have a deep understanding of the scientific disciplines that underlie the physical and physiological behavior of various drug formulations for oral and parenteral delivery, as well as a working knowledge of the regulatory guidelines relevant to GMP work. Additional requirements include strong writing skills, extensive experience authoring technical reports and regulatory documents, as well as with the selection, contract negotiation and management of multiple concurrent external relationships with CROs, consultants, and other vendors.