SUMMARY/JOB PURPOSE:

The Associate Director, Analytical Development is responsible for establishing and supervising an in-house Analytical Development group and manage the day-to-day activities directed toward the development and validation of analytical methods for the testing of Exelixis Investigational New Drug Substances and New Drug Products. The incumbent is responsible for the transfer of methods to contract laboratories and manage activities at contract laboratories, including stability studies.

Essential Duties And Responsibilities:

• Manage analytical chemistry activities both internally and at contract laboratories with best practices in support of Exelixis developmental from discovery to NDA

• Contribute effectively towards strategic and tactical development of project plans with key emphasis on analytical aspects and phase appropriate development

• Provide strategic and tactical input toward assessing and identifying any at risk or potential problematic areas within analytical testing activities at CMOs and provide effective solutions to mitigate before these areas result in any issues

• Perform hands-on documentation and data review and provides significant contributions and oversight to contract labs for protocols, deviations, investigations, CAPA’s, reports, stability data, trending, specification setting, shelf-life/retest dating, using where applicable, current regression analysis practices and other relevant statistical techniques

• Work closely with contract labs to directly oversee transfer of methods, validation, and QC testing to ensure they are executed successfully and with best practices

• Manage, supervise, mentor, and develop a team of Analytical Development staff across various development programs

• Serve as department representative and subject matter expert on Development project teams

• Author, prepare and review relevant sections of CMC submissions in support of regulatory filings

• Collaborate effectively within CMC, QA and RA and outside contract laboratories with excellent communication to maintain strong relationships

• Stay current with changing regulatory requirements regarding analytical testing

• Help to identify and draft work instructions/SOP for relevant analytical functions

Supervisory Responsibilities:

• Supervises staff, including hiring, scheduling, and assigning work, reviewing performance, and recommends salary increases, promotions, transfers, demotions, or terminations.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS in Analytical Chemistry or related field and a minimum of eleven years of related experience; or,

• MS in Analytical Chemistry or related field and a minimum of nine years of related experience; or,

• Ph.D. in Analytical Chemistry or a related field and a minimum of five years of related experience; or,

• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• Experience in Analytical Development in the pharmaceutical industry

• Experience developing and validating analytical methods, specifically HPLC methods, for testing small molecule drug substances and drug products, including solid oral dosage formulations and IV formulations

• Experience conducting stability programs

• Experience working with contract laboratories is desirable

• Hands on experience with analytical instrumentation including HPLC and GC

Knowledge/Skills:

• Comprehensive knowledge of regulatory and compliance issues as they relate to the development of pharmaceutical products

• Excellent written and oral communication skills

• Ability to work effectively in a team setting

JOB COMPLEXITY:

Working Conditions:

• Environment: primarily working in office with occasional supervisory in laboratory environment

• Travel as required (less than 10%)

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $173,000 - $246,000 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. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

DISCLAIMER 
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.  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.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.