Job Summary
A commercial-stage immunology company is seeking a Remote Formulation and Drug Product Development Director.
Core Responsibilities Include:
- Providing technical leadership in formulation development to support pre-clinical and clinical programs
- Working with non-clinical and clinical teams to design and execute studies to support product use and stability
- Supervising outsourced drug product development with Contract Manufacturing Organizations
Must meet the following requirements for consideration:
- 20 years with BS; 17 years with MS; 12 years with PhD
- Experience in protein or viral vaccine formulation and drug product development
- Understanding of drug degradation pathways and design of accelerated stability and excipient screening studies
- Experience operating in both early and late-stage cGMP clinical programs
- Significant proficiency in drug product processing unit operations including filling, lyophilization, capping
- Strong biophysical and biochemical protein analytical skills