Analytical Data Review Manager

Role Summary

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.

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.
• Responsible for the review of documentation related to the following tests for in-process and finished product samples: 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.
• Responsible for the review of documentation related to raw material tests such as but not limited to the following: Identification by IR, Limit tests (Residue on Ignition, Heavy Metals), Titration, Particle Size, and Viscosity
• Communicate with CMOs to resolve issues/questions identified from analytical data review
• Collaborate internally as well as with CMOs to investigate OOS and deviations
• Responsible for the review of protocols and reports such as process validations, analytical method validations.
• Update/Write methods, SOPs, and product specifications as required.
• Perform other duties as assigned with minimal instructions.

Qualifications

• BS/BA degree in related discipline and a minimum of seven years of related experience; or,
• MS/MA degree in related discipline and a minimum of five years or related experience; or,
• Equivalent combination of education and experience

Experience

• Analytical laboratory experience in the Pharmaceutical industry using and/or reviewing techniques such as HPLC, GC, UV, IR, TLC, KF required.
• Hands-on experience reviewing data, documents, notebooks, and worksheets generated in an analytical test laboratory is preferred.
• Experience using laboratory instrument data acquisition software (Empower, Chemstation, Chromeleon, etc.) required.

Knowledge/Skills

• Must have strong mathematical skills; ability to understand, review and check calculations used to perform analytical testing using various instruments and generated during analytical laboratory testing procedures in a GMP lab required.
• Requires knowledge of Good Manufacturing Practices, FDA/ICH Guidelines, and compendial references (USP/Ph. Eur., etc.) as they apply to data/document review preferred.
• Experience with Microsoft Office (Word, Excel, Power Point, etc.) required.
• Ability to communicate effectively with chemists by explaining deficiencies in the documentation and providing constructive feedback to minimize recurring errors required.
• Demonstrated ability to take the initiative to organize and prioritize work tasks and to work independently required.

Additional Requirements

• Environment: primarily working indoors in an office environment
• Travel required: 0 ‚Äì 5% travel required