Senior Scientist, Genomic Medicine Unit - BioAnalytics
Sanofi is seeking a highly motivated Senior Scientist and to join the growing Gene Therapy Bioanalytical Development team in the Sanofi Genomic Medicines Unit. Our department is currently located in Framingham, MA, but will be moving to Waltham, MA shortly. The candidate is expected to have a strong scientific background in both qPCR and ddPCR methods to detect transgene expression and the presence of impurities in gene therapy products. This role requires skills and interests in performing method development, management of critical reagents and early phase GMP testing. The successful candidate will lead the design and development of PCR-based methods to support preclinical and early phase clinical lot release and stability testing for viral and non-viral gene therapy products. In addition, the senior scientist will also have familiarity with analytical method technical transfers to CROs/CMOs.
Serve as a PCR SME for gene therapy analytics at Sanofi
Define scientific approaches and analysis methods for gene therapy potency and impurity bioassays.
Lead the development, qualification and validation of molecular assays in a regulated GMP environment.
Lead troubleshooting initiatives ensuring efficiency of approach and define workstreams required for the generation of complex reagents
Participate in the execution of lot release and stability tests for drug substance and drug product.
Efficiently prepare GMP data packages. Lead investigations into deviations and CAPA resolutions as appropriate.
Ensure timely completion and delivery of analytical results and documentation (technical reports, SOPs, etc.) to support early phase product development.
Provide guidance and mentorship to help junior staff nurture their career growth.
Lead the establishment of a critical reagents program within the bioanalytical group.
PhD. in Biochemistry, Biological Sciences, or related discipline with 4 years of relevant experience working in the biotechnology/pharmaceutical industry, or Master’s Degree and at least 8 years of relevant experience or Bachelor’s Degree and at least 10 years of relevant experience.
Proven experience in developing and qualifying/validating analytical methods to support product development and regulatory filings for viral and/or non-viral gene therapy products.
Strong background in molecular methods (e.g. transgene expression residual impurity assays), excellent method troubleshooting skills, as well as appropriate experience in developing data analysis approaches according to regulatory guidance).
Working experience in a GMP environment and ability to adhere to all appropriate GMP standards (e.g. invalid result investigations, deviations, and CAPAs) will be considered advantageous.
Good understanding of regulatory requirements for early and late-stage development of Gene Therapy products including compendial requirements as well as requirements associated with the assessment of critical quality attributes, control strategies, stability, and comparability as outlined in ICH Guidelines and FDA guidance documents.
Excellent verbal and written communication skills and experience working cross-functionally.
Demonstrated ability to work in a matrixed environment and interact productively with associates, scientists and management at various levels, both locally and internationally
Understanding of MOA for different gene therapy therapeutics.
Familiarity with software packages to analyze dose-responses, statistical analysis and parallelism or equivalence testing.
Experience with ELISA, cell-based platforms to characterize Gene Therapy products.
General understanding of statistical principles supporting method performance and robustness assessments as well as Design of Experiment approaches used for method development/optimization.
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