Scientist II, Drug Substance Manufacturing

SUMMARY/JOB PURPOSE:

Responsible for the comprehensive review of documents and data analysis related to executed batch record packages, master batch records, protocols, reports, deviations, change controls, specifications, and risk assessments generated within the Commercial Drug Substance Manufacturing Group and related Contract Manufacturing Organizations (CMOs) to ensure compliance with all established and approved procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Review executed batch records, master batch records, associated data, and manufacturing documents within the Exelixis Commercial Drug Substance Manufacturing Group and related Contract Manufacturing Organizations (CMOs) for accuracy and completion and to ensure the work performed is in compliance with applicable procedures related to manufacturing of commercial drug substance/API.
• Review documentation related to routine commercial manufacturing of raw materials, intermediates, and commercial drug substance/API, and gather and collect data pertaining to manufacturing process parameters.
• Maintain batch record review tracker to ensure timely batch release and communicate the progress and the expected completion dates with the batch records review team.
• Review protocols, change controls, and reports related to process validations and/or equipment and material qualifications, as well as other documentation such as specifications and risk assessments.
• Perform data collection, trending, and analysis for Continuous Process Verification (CPV) and Key Performance Indicator (KPI) manufacturing metrics utilizing statistical analysis software.
• Communicate with CMOs to resolve issues and questions identified from executed batch records.
• Collaborate internally as well as with CMOs to investigate deviations, out-of-specification (OOS), or out-of-trend (OOT) results.
• Archive documents as required per internal procedures.
• Perform other duties as assigned with minimal instructions.

SUPERVISORY RESPONSIBILITIES:

• None.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• Minimum BS/BA degree in chemistry, chemical engineering, life sciences or related discipline and a minimum of 1 year of related experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• A minimum of 1 year in the GMP Pharmaceutical Industry required.
• A combination of 2+ years of prior hands-on experience in an organic chemistry laboratory, process chemistry laboratory, or drug substance/API manufacturing setting is preferred.
• 2+ years of prior hands-on experience reviewing data, documents, notebooks, and worksheets generated in an organic chemistry laboratory, process chemistry laboratory, or drug substance/API manufacturing setting is required.
• Must have knowledge in various types of analytical instrumentation and techniques used in an organic chemistry laboratory, process chemistry laboratory, or drug substance/API manufacturing setting.

Knowledge/Skills:

• Knowledge of Good Manufacturing Practices (GMPs) as applicable to data/document review is required.
• Must have strong mathematical skills and ability to understand, review, and verify calculations used to perform analytical testing using various instruments in a GMP lab setting.
• Experience with Microsoft Office (Word, Excel, PowerPoint, etc.) is required.
• Experience with statistical analysis software (JMP, etc.) is preferred.
• Ability to communicate effectively with chemists and cross-functional colleagues by explaining deficiencies in documentation and providing constructive feedback to minimize recurring errors is required.
• Demonstrated ability in taking initiative to organize and prioritize work tasks independently is required.

WORKING CONDITIONS:

• Environment: Primarily working in the office full-time.
• Travel may occasionally be required.

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