Supervisor Genomic Medicine Bioanalytics, CT Flow Cytometry - Second Shift
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Position Overview/Department Description
This position resides within the Genomic Medicine Unit (GMU), a part of Sanofi’s CMC Development organization. The GMU Cell Therapy Flow Group has the overall responsibility to establish phase appropriate control strategies and to develop, qualify, and validate robust flow cytometry methods to support in-process, 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.
We are looking for a skilled and highly motivated scientist with broad expertise in immunophenotyping and cell sorting method development to join the GMU CT QC Flow group in Framingham, MA. This is a second shift position.
Overview of role:
The primary accountability is to perform and develop flow-based analytical methods, cGMP testing, and validation activities. In addition, the GMU CT Flow Group 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.
Performs all activities in accordance with cGMP requirements and reports discrepancies. Initiates and complete laboratory discrepancy events within expected timelines
Provide and supervise analytical support for manufacturing operations, including qualification of in-process and release methods and assist in tech transfer internally and externally in support of GMP manufacturing and release of clinical material.
Acquire a working knowledge of flow cytometry for routine testing, method validation and method transfer process
Documents testing activities and results, ensuring completeness and accuracy per cGMP
Contributes toward the development, revision, application, maintenance, validation and review of method SOPs. Initiates and follows up on change request for SOP revision.
Ensure high-quality, timely documentation in electronic laboratory notebooks and technical reports which support regulatory filings.
Perform assay training and supports qualification of junior analysts
Provide technical oversight and manage the workload for a few junior analysts
Other duties as assigned
Ph.D. in Molecular Biology/Biochemistry/Biology or related discipline or Master’s degree with a minimum of four years of relevant industry experience, or a Bachelor’s Degree with a minimum of six years of relevant industry experience
Experience in a cGMP environment and ability to adhere to all appropriate cGMP standards (e.g. invalid result investigations, deviations, and CAPAs)
Experience leading a small team
Able to follow instructions and SOPs precisely and able to keep accurate and contemporaneous documentation
Able to learn new skills rapidly and achieve proficiency. Detail-oriented with good written and verbal communication skills
Ability to solve problems of moderate complexity and troubleshooting as necessary
Team player with good interpersonal skills
Self-motivated with excellent organization, time-management, and communication skills
Experience authoring SOPs
Previous working experience in aseptic techniques and in flow cytometry is required
Experience with transferring methods between groups in a cGMP environment
Experience with validation and transfer analytical methods
Experience in maintenance of GMP laboratory, laboratory equipment, and the status of pipettes and supplies.
Experience using Quality by Design (QbD) principles and have used Design of Experiment (DOE) approaches for method development/optimization
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
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