Manager of Small-Molecule Formulation Development and Drug Product Manufacturing

Location
Hayward, California
Salary
TBD
Posted
Jun 12, 2018
Ref
#PC-MGR
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

This newly created position will report to the VP of Preclinical Development & SM CMC.  

Position Description

The Manager 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. He/She 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. He/She will initiate, evaluate, and negotiate contracts and manage CROs for formulation development and Drug Product GMP manufacture. He/She will oversee the development and validation of analytical methods and assume responsibility for multiple long-term stability studies for Drug Product. He/She will collaborate with Quality Assurance to ensure the quality of the company’s manufactured products. He/She will participate in the generation and finalization of technical reports and regulatory documents in the areas of responsibility.

Position Requirements

Minimum requirements include a Ph.D. in pharmaceutical sciences or a Pharm.D. degree, at least 5 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. He/She must have a deep understanding of the scientific disciplines that underlie the physical and physiological behavior of various drug formulations for oral delivery, as well as a working knowledge of the regulatory guidelines relevant to GMP work. The ideal candidate will also have experience in the development of formulations for parenteral delivery. Additional requirements include strong writing skills, experience authoring technical reports and regulatory documents, and experience with the selection, contract negotiation and management of multiple concurrent external relationships with CROs, consultants, and other vendors.