Sanofi Group Scientist, BioAnalytics Genomic Medicine in Framingham, Massachusetts
Position Overview :
We seek an energetic and highly motivated Scientist to join the Bioassay and Molecular Analytical Development (BAM) group within the Genomic Medicine Unit (GMU)-Bioanalytics group. The successful candidate will lead the design and implementation of bioassays and molecular assays to support gene and cell therapy programs in all phases of clinical development. S/he will develop, qualify, and implement analytical methods for drug product release and characterization within a GMP environment. In addition, the scientist will also have familiarity with analytical method transfers to CROs/CMOs.
Participate in phase appropriate development, qualification/validation of robust assays for the characterization and GMP release of cell and viral or non-viral gene therapy drug products and critical raw materials per ICH and regulatory guidelines.
Develop and maintain method to evaluate residual impurities like DNA, residual AAV and other viral/host cell proteins and process impurities.
Provide expertise for enhancing existing assays, and implementation of new ideas and technologies.
Collaborate with external partners, CMOs to monitor outsourcing activities, manage timelines, and ensure deliverables.
Maintain a GMP-compliant laboratory environment and ensure departmental SOPs, internal Sanofi standards and applicable regulations are consistently followed.
Write/review method protocols, assay qualification and validation plans/reports and ensure that the documents adhere to GxP requirements and ICH guidelines.
May participate in CMC teams as an ATL responsible for defining the analytical testing plan including the definition of drug product CQAs and development of appropriate analytical assays to measure these attributes in cell and gene therapy programs.
PhD. in Biology, Biochemistry, Biological Sciences, or related fields or a Master's degree with at least 4 years of relevant experience or a Bachelor's degree with at least 6 years of relevant experience.
Strong background in cell based and molecular methods, excellent method troubleshooting skills, as well as appropriate data analysis approaches.
Excellent verbal and written communication skills.
Working experience in a GMP environment and ability to adhere to all appropriate GxP standards will be considered an advantage.
Demonstrated ability to work in a matrixed environment and interact productively with associates, scientists, and management at various levels, both locally and internationally.
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.