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 and manage performance metrics Oversee direct reports from the stability group Manage activities related to drug substance and drug product stability testing, both commercial and clinical: Write and review stability protocols according to International Conference on Harmonization (ICH) guidelines. Manage and monitor contract laboratory stability testing to ensure adherence to the stability scheduled outlined in the stability protocols. Review stability data (including raw test data). Trend and track stability data and to determine drug product shelf life/retest date according to ICH guidelines. Investigate out of trend or out of specification results according to industry best practices. Manage, chair and present in regularly scheduled stability committee meetings. Write final stability reports for completed stability studies. Review and assess temperature excursions during storage and/or during transportation. Generate certificate of analysis and retest memos, setting and justifying specifications for both release and stability testing, and regulatory document controls. Supervisory Responsibilities: Supervise staff, including hiring, scheduling, and assigning work, reviewing performance, and recommends salary increases, promotions, transfers, demotions, or terminations. Provide direction to other individuals. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: BS/BA degree in related discipline and a minimum of eleven years of related experience; or, MS/MA degree in related discipline and a minimum of nine years of related experience; or, PhD degree in related discipline and a minimum of five years of related experience; or, Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: GMP experience preferred Technical laboratory experience in small molecules and solid oral dosage preferred. Experience in Pharmaceutical industry preferred. Knowledge/Skills: Has extensive experience in relevant industry/profession and…