Job Description

Analytical Data Review Manager page is loaded## Analytical Data Review Managerlocations: Alameda, CAtime type: Full timeposted on: Posted 2 Days Agojob requisition id: JR6400**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.* 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.**Supervisory Responsibilities:*** No supervisory responsibilities**EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:****Education/Experience:*** 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/The 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 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.**JOB COMPLEXITY:****Working Conditions:*** Environment: primarily working indoors in an office environment* Travel required: 0 – 5% travel required#LI-HG1*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 severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $109,000 - $154,500 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.***Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial. As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission. Cancer is our cause. Make it yours, too. #J-18808-Ljbffr Exelixis, Inc.

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