Job Overview/Department Description:
This position resides within the newly established Genomic Medicine Unit (GMU) which is part of Sanofi’s CMC Development organization. The Next Generation Sequencing (NGS) core group will support sequence analysis for gene therapy, cell therapy and mammalian products. Reporting into the Head of GMU Bioanalytics, the Associate Director, NGS Core Leader will lead a group of NGS and molecular specialists. The NGS group’s main mission is to develop and maintain NGS solutions and data analysis pipelines to support product characterization and GMP release of gene and cell therapy products, support vector design, cell line development and cell and viral bank generation. In additional, the NGS group will also provide investigational support for adventitious agent detection and identification.
- Oversee the development, qualification, validation and transfer of NGS and related methods as well as data solutions in accordance with ICH and internal Sanofi guidance documents. These may be for GMP and non GMP use and involve developing NGS methods and other sequencing workflow associated instrumentation
- Provide mentorship to direct reports within the NGS core laboratories including training staff on protocols and equipment and maintenance procedures
- Oversee the NGS core labs and equipment to ensure that they are well maintained and meet the requirements for their GMP and non GMP use
- Work with ITS, QA, Data Sciences, and other functions to define best business practices and guidance for NGS and data analytics solutions
- Set the strategy for evaluating and implementing new next-gen sequencing technologies and data analytics platforms within Bioanalytics, with a particular emphasis on developing an automated NGS platform with state of the art data analytics pipeline in collaboration with the Global Data Analytics and BioA automation teams
- Collaborate cross functionally within Bioanalytics and CMC development to define and prioritize projects that require the development of NGS solutions for biologics, gene and cell therapy products
- Coordinate with other Bioanalytics group heads, Cell line development, GM Predevelopment (Vectorology and Expression Platform Development), GMU Research, Vector Core, and other user groups to ensure the appropriate resources are trained and available to meet these deliverables
- Act as a technical SME for NGS, providing advice and troubleshooting technical and logistical issues within BioA and across the BioDev/IA/MSAT interfaces
- Develop relationships with external vendors and other industry leaders
- Represent Sanofi through publications, presentations and consortium participation.
- Represent Bioanalytics in setting Sanofi company-wide strategic NGS related initiatives, including authoring guidance documents
- PhD degree in a biochemistry, biophysics, chemistry or a related discipline with a minimum of 8 years of relevant industry experience or a Masters or Bachelors degree with a minimum of 12 years of relevant industry experience.
- Deep expertise in NGS systems and data workflows (including nucleic acid extractions, library preparation, enrichment methods, methylation sequencing, etc.).
- Experience with developing and validating novel NGS assays for viral, gene and cell therapy products in a GxP setting
- Experience working in analytical development or product characterization with proven troubleshooting skills
- Experience leading the implementation new technologies across cross functional teams for the analysis of large molecule biologics, cell or gene therapy.
- A strong record of accomplishment in the field, including publications, patents, and presentations
- Excellent communication skills
- Experience working in a GMP testing environment
- Demonstrated ability to work in highly skilled and matrixed teams in a fast-paced, entrepreneurial, and technical setting
- Experience working with external collaborators to develop innovative technologies
- Experience leading teams in the development, qualification/validation and transfer of analytical methods to internal or external collaborators