• Job Description

  Req#: R2704039

  Senior Scientist, Genomic Medicine Unit

  • Location: Amsterdam, the Netherlands
  • Job type: Permanent, full time
  • Might occasionally require evening and weekend work

  About the job

  Join our Cell Therapy Amsterdam as the Senior Scientist, Genomic Medicine Unit. In this role you will be responsible for developing immunological, cell-based, and analytical methods, cGMP testing, and validation activities. In addition, as a part of the GMU CT AD/QC team, you will be responsible for introducing new technologies and ways of working to enable rapid progression of various early-stage cell and gene therapy candidates into the clinic.

  About our team

  Cell Therapy Amsterdam (Kiadis), a Sanofi Company, is a biopharmaceutical R&D unit dedicated to accelerating novel cell-based therapies for cancer patients. We are at the forefront of cell therapy science and drive innovation in NK-cell therapy with cutting-edge R&D and PM21 production capabilities.

  Genomic Medicine Unit (GMU) is part of Sanofi’s CMC Development organization. The GMU Cell Therapy Analytical Development and Quality Control (CT AD/QC) group has the overall responsibility to establish phase appropriate control strategies and to develop, qualify, and validate robust analytical methods to support release and characterization testing of different cellular therapy candidates. In addition, the group supports cGMP-compliant release and stability testing of clinical supplies performing both the product-specific as well as compendial methods.

  Main responsibilities

  • Define scientific approaches and analysis methods for bioassays
  • Participate in the development, qualification, and validation of cell-based bioassays and molecular assays in a regulated GMP environment
  • Develop, qualify, and transfer analytical methods to support drug substance and drug product release and stability testing
  • Evaluate and implement new technologies within the AD/QC department, with an emphasis on state-of-the-art immunology, cell-based, and analytical assays
  • Plan, prioritize, and execute simple and complex experiments with the relevant controls, independently
  • Troubleshoot existing protocols to increase method performance
  • Participate in the execution of lot release and stability tests for drug substance and drug product and documentation of data packages under GMP. Lead investigations into deviations and CAPA resolutions as appropriate
  • Write analytical sections of IND/IMPD filings
  • Ensure timely completion and delivery of analytical results and documentation (technical reports, SOPs, etc.) to support product development during clinical phases
  • Leads internal and external assay transfers consistent with established Sanofi procedures
  • Design and execute advanced experimental plans and data analysis methods; write and review high quality reports
  • Originate ICH compliant stability protocols and reports, coordinate, review, trend, and report stability test data for clinical drug product
  • - Qualifying (or managing qualification of) critical reagents, qualified materials (such as assay controls), and analytical reference standards

  About you

  • PhD in cell biology, immunology, hematology, or other relevant disciplines with several years of experience in a related field, preferably in industrial cell therapy or other biopharmaceutical analytical development or Masters degree with 8 years of industry experience, or a Bachelors degree with 10 years of industry experience
  • Excellent knowledge and hands-on experience with primary cell-based potency, flow cytometry and cell-based assays and ELISA, with other molecular and/or biochemical techniques, and development of biological methods according to ICH guidelines
  • Experience with assay qualification/validation, assay transfer
  • Demonstrating problem solving, technical writing and verbal communication skills, the ability to clearly conveys information and concepts/principles, ability to multi-task effectively with a strong sense of quality and ownership
  • Demonstrated ability to perform work that consistently requires independent decision making and the exercise of independent judgment and discretion as well as Self-motivated with excellent organization and time-management skills
  • Demonstrated team player with experience contributing to multi-disciplinary project teams
  • Innovative, critical, and creative thinker; not afraid to propose disruptive solutions
  • Experience in a GMP environment and ability to adhere to all appropriate GMP standards (e.g. invalid result investigations, deviations, and CAPAs) and the application of QbD principles and tools e.g. DOE to develop analytical methods (preferred Qualifications)
  • Knowledge of cell therapy regulatory guidance’s
  • Verbal and written fluency in English

  Pursue progress. Discover extraordinary.

  Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

  At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

  Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

  #LI-EUR

  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.

• About the company

  Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health.

Notice