Exel

Associate Director, Stability Management

Alameda, CA · Director

Sponsorship not specified$172k-$244kDetected 31 days ago

StatisticsGMPCommunicationCollaborationWriting

About the role

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.

Establish and manage performance metrics
Manage and monitor contract laboratory stability testing to ensure adherence to the stability scheduled outlined in the stability protocols.
Manage, chair and present in regularly scheduled stability committee meetings.
Generate certificate of analysis and retest memos, setting and justifying specifications for both release and stability testing, and regulatory document controls.
Manage activities related to drug substance and drug product stability testing, both commercial and clinical:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.

BS/BA degree in related discipline and a minimum of eleven years of related experience
MS/MA degree in related discipline and a minimum of nine years of related experience
PhD degree in related discipline and a minimum of five years of related experience
Travel required - 10% of travel required
It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Technical laboratory experience in small molecules and solid oral dosage preferred.
Experience in Pharmaceutical industry preferred.

Has extensive experience in relevant industry/profession and area of specialization.
Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
Has good general knowledge of other related disciplines.
Applies strong analytical and business communication 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

The base pay range for this position is $172,000 - $244,000 annually.
The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.
Supervise staff, including hiring, scheduling, and assigning work, reviewing performance, and recommends salary increases, promotions, transfers, demotions, or terminations.

The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.

If you have a disability and need an accommodation in relation to the application and/or recruitment process, please email us at: recruiting@exelixis.com.

This listing is sourced directly from Exel's careers page and normalized into a canonical job model.