Associate Director, Stability Management

SUMMARY/JOB PURPOSE:

The Associate Director, Stability Management is responsible for the establishment and management of the stability group withing Exelixis CMC department. This role oversees the overall strategy and oversight of Exelixis' stability and reference standard programs for drug substance, drug product and reference standard for both the commercial and clinical programs. Additional responsibilities include, establishing Exelixis stability policies, procedures, and performance metrics internally and externally with CMOs. Will provide oversight over the CMOs' execution of the stability studies, authoring of the stability protocols, interim stability reports, and final stability reports. This role requires strong personnel resource management, communications, technical writing, and statistical analysis skills.

Essential Duties And Responsibilities:

• Establish Exelixis stability policies and procedures

• Establish a...

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