Job Details

SUMMARY/JOB PURPOSE

The Analytical Data Review Manager is responsible for the comprehensive review of documentation, analytical data, protocols, and reports generated within the Analytical Chemistry department and related third?party documents to verify and ensure that the laboratory records are in compliance with all established and approved procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Review laboratory documents within Exelixis and related contract manufacturers (CMO) to ensure that they are accurate and complete, and that the work performed is in compliance with applicable procedures and analytical methods.


• Review data documented by CMO laboratory personnel within laboratory notebooks, worksheets, and logbooks (e.g., instrument use and maintenance logbooks).


• Review audit trail to ensure that the electronic data were generated according to applicable procedures.


• Review documentation related to in?process and finished product tests: Appearance, Assay, Content Uniformity, Blend Uniformity, Hardness, Loss on Drying, Water Content, Related Substances/Impurities by HPLC, Residual solvent/Impurities by GC, Dissolution, and Cleaning Verification/Validation.


• Review documentation related to raw material tests such as Identification by IR, Limit tests (Residue on Ignition, Heavy Metals), Titration, Particle Size, and Viscosity.


• Communicate with CMOs to resolve issues and questions identified from analytical data review.


• Collaborate internally and with CMOs to investigate OOS and deviations.


• Review protocols and reports such as process validations and analytical method validations.


• Update or write methods, SOPs, and product specifications as required.


• Perform other duties as assigned with minimal instructions.

SUPERVISORY RESPONSIBILITIES

No supervisory responsibilities.

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS

Education / Experience

• BS/BA degree in a related discipline and a minimum of seven years of related experience; or


• MS/MA degree in a related discipline and a minimum of five years of related experience; or


• Equivalent combination of education and experience.

Experience / Ideal for Successful Entry into Job

• Analytical laboratory experience in the pharmaceutical industry using and/or reviewing techniques such as HPLC, GC, UV, IR, TLC, KF.


• Hands?on experience reviewing data, documents, notebooks, and worksheets generated in an analytical test laboratory.


• Experience using laboratory instrument data acquisition software (Empower, Chemstation, Chromeleon, etc.).

Knowledge / Skills

• Strong mathematical skills; ability to understand, review, and check calculations used in analytical testing.


• Knowledge of Good Manufacturing Practices, FDA/ICH Guidelines, and compendial references (USP/Ph. Eur., etc.).


• Experience with Microsoft Office (Word, Excel, PowerPoint).


• Ability to communicate effectively with chemists by explaining deficiencies in documentation and providing constructive feedback.


• Demonstrated ability to take initiative to organize and prioritize work tasks and to work independently.

JOB COMPLEXITY

Feature not specified.

WORKING CONDITIONS

• Environment: primarily working indoors in an office environment.


• Travel required: 05%.

COMPENSATION

The base pay range for this position is $109,000 $154,500 annually. The base pay may vary by geographic region and depends on the candidates knowledge, skills, experience, and internal equity.

Exelixis offers comprehensive benefits including a 401(k) plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Additional rewards include a discretionary annual bonus program, options for long?term incentives, stock purchase options, 15 accrued vacation days in the first year, 17 paid holidays (including a company?wide winter shutdown in December), and up to 10 sick days per 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.

EEO STATEMENT

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, or basis of disability or any other federal, state or local protected class.