Sanofi Group Manager Laboratory US in Swiftwater, Pennsylvania

Laboratory Manager Quality Control Analytical Support

(Swiftwater, PA) -The Laboratory Manager in Quality Control Analytical Support will provide technical support to the Quality Control laboratories while strictly adhering to Sanofi Pasteur policies and procedures and cGMPs. The candidate filling this position will work to insure tasks are completed in a timely and compliant manner. The candidate will serve as a department subject matter expert for PCR, ELISA, and other biological testing methodologies. The candidate will perform method validation and transfer activities for Quality Control methods. The candidate is required to complete Safety and Compliance training and associated training modules.

Key accountabilities:

*Method Validation: Performs current tasks by strictly adhering to SOP, SWI, Federal Regulations, cGMP, training modules (when applicable), sanofi pasteur policies and procedures and safety procedures. Executes protocols and QC testing instructions as defined by management to meet demands of Production, Stability, and Project Independent Demand requirements. Timely completion of required paperwork and documentation as required.

*Laboratory Support: Serves as a subject matter expert supporting the QC laboratories for PCR, ELISA, and other biological testing methodologies supporting both licensed products and new vaccine projects.

*Training: Attends/Contributes to scheduled team meetings, department meetings, and safety meetings. Document review. Safety and compliance training. Module/Task training as assigned and offer suggestions for improvement. Professional/Technical development training on/ off-site as assigned. Train others on any processes, procedures,tasks, and equipment they are proficient on.

*Compliance: Demonstrate proficiency in use and knowledge of change controls, CAPAs, validation deviations, and the QA deviation system. Notifies laboratory manager of any deviations or issues and initiates incident investigations as required. Perform initial deviation investigations through analyst interview and equipment inventory. Develop a working knowledge of appropriate compendia and/or regulatory guidance’s. All other assigned duties.

Basic Qualifications:

*BA/BS in life science

*7 years of relevant experience in a cGMP controlled/pharmaceutical industry or testing laboratory.

OR

*MS in life sciences

*5 years of relevant experience in a cGMP controlled/pharmaceutical industry or testing laboratory.

AND

*Excellent working knowledge of cGMPs (US, Canada, Japan, Europe).

*Experience in QC testing of marketed products and/or clinical product is required.

*Experience with PCR, ELISA, microbiology and cell culture is required

Preferred Qualification:

*Experience in method validation and method transfer is beneficial.

*Experience in SAP, LabWare, & Trackwise is beneficial.

Sanofi Pasteur SA and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life