Job Responsibilities/Department/Skills

This position with be in the Analytical Development/Quality Control (AD/QC) group of GMU at Sanofi, Framingham/Waltham, MA for viral and non-viral gene therapy products. The group has the overall responsibility of analytical method development, qualification, validation and troubleshooting of the analytical assays as well as release of clinical trial material, under GxP environment, for early to up to Ph II stage.

Primary responsibilities of the position include

• Routine Testing of samples in a GxP environment as per the method SOPs will be the primary responsibility of the position. The individual shall focus on various separation science platforms (different modalities of HPLC/UPLC including normal and reverse-phase HPLC, SEC, IEX, LC-CAD) and their interface with mass spectrometry where appropriate, capillary electrophoresis, spectrophotometric assays and ELISA as well as raw material testing using Raman Spectrometry.

• In addition, the suitable candidate shall also have the opportunity to participate in analytical method development, qualification, validation and troubleshooting as required.

• Adherence to good documentation practices are required.

• Writing method protocols, assay qualification and validation plans in accordance with the ICH guidelines.

• All associated tasks with a given testing episode would also comprise part of their duties such as preparing, ordering, and maintaining stocks of necessary reagents, solutions and supplies as needed.

• The candidate will be required to manage work assignments, analyze and interpret test results, and conduct necessary troubleshooting and consult with supervisor as needed.

• Experience of working collaboratively in a matrix team environment is a plus.

Basic qualifications

• B.S. in Biochemistry or related area with 1-3 years of experience working in an analytical method development laboratory

• A strong background in HPLC including running instrumentation from different vendors, troubleshooting and data analysis is required. Use of tools such as Chemstation/OpenLab/Empower is highly desirable.

• Additionally, experience in SDS-PAGE and other formats of electrophoresis such as capillary electrophoresis and spectrophotometric assays would be beneficial for the position.

• Working experience in GxP environment and ability maintain good records of all the work performed and adhere to all appropriate GxP standards as applicable including initiation of invalid result investigations, deviations and document changes.

• Successful candidate is expected to be very organized, driven and a team player.

Sanofi Inc. 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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.