Scientist - Analytical Development - Quality Control - Genomic Medicine Unit
This position with be in the Analytical Development / Quality Control (AD/QC) of Genomic Medicine Unit (GMU) at Sanofi, Waltham, MA. Note: this team currently works in Framingham, MA but it set to move in early October 2023. The team 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 GMP environment, for early to up to Phase II stage.
The primary responsibility of the job is routine GMP sample testing as per the method SOPs in place.
This individual shall work with different gene/cell therapy modalities such as AAV and LNP and apply various separation science platforms (HPLC/UPLC – Reverse phase, SEC and IEX with detections like UV, FLD, CAD and QDa; CE; cIEF; GC).
While emphasis will be on GMP sample testing, support towards method development, qualification/validation as needed is expected
Writing analytical method SOPs and assay qualification/validation protocols and reports in accordance with the ICH guidelines.
All associated tasks with a given testing episode would also comprise part of his/her duties such as preparing, ordering, and maintaining stocks of necessary reagents, solutions and supplies as needed.
This individual will be required to manage work assignments, analyze and interpret test results, and conduct necessary troubleshooting and consult with supervisor as needed.
Degree in Chemistry, Biochemistry or other related disciplines.
Ph.D. / M.S. / B.S. with 0 / 3-4 / 5-7 years of experience in an industrial GMP QC testing lab.
A strong background in HPLC/UPLC analysis including operating systems of different vendors, troubleshooting, maintenance and data analysis is required.
Working experience in GMP environment and ability maintain good records of all the work performed and adhere to all appropriate GMP standards as applicable including initiation of OOS/OOT investigations, deviations and change controls.
Being organized, driven and a team player.
Ph.D. / M.S. with 2 / 5 years of experience in an industrial GMP QC testing lab.
Experience with Analytical development and method qualification/validation.
Proficient with Empower 3 software.
Experience with capillary electrophoresis, capillary isoelectric focusing assays and gas chromatography.
Working Experience with AAV and LNP.
Deep knowledge in chemistry of DNA, RNA and protein.
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.
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.