Scientist, Genomic Medicine Bioanalytics
Waltham, Massachusetts, Framingham, Massachusetts
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Position Overview/Department Description
We are seeking an energetic and highly motivated Scientist to join the Bioassay and Molecular (BAM) Analytical Development group within the Genomic Medicine Unit (GMU), located in Waltham, MA. The GMU Bioanalytics group has the overall responsibility to establish phase appropriate analytical control strategies and to develop, qualify, and validate robust analytical methods to support release and characterization testing of different gene 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.
The primary accountability is to develop molecular and cell based methods, GMP testing, and validation activities. In addition, the GMU BAM team will be responsible for introducing new technologies and ways of working to enable rapid progression of various early stage gene therapy candidates into the clinic.
Develop, qualify, and transfer analytical methods to support drug substance and drug product release and stability testing.
Evaluate and implement new technologies within the Analytical Development department, with an emphasis on state-of-the-art molecular and cell based and binding based assays.
Plan, prioritize and execute simple and complex experiments with the relevant controls independently.
Troubleshoot existing protocols to increase method performance, throughput and ergonomic control.
Write analytical sections of IND/IMPD filings.
May represents analytical development in cross functional meetings for projects and analytical initiatives.
Work in a GMP-compliant laboratory environment and ensure departmental SOPs, internal Sanofi standards and applicable regulations are consistently followed.
Leads internal and external assay transfers consistent with established Sanofi procedures.
May provide technical oversight and manage the workload for a few junior analysts.
Ph.D. in Biology/Biochemistry 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.
Strong background in cell and molecular methods (e.g. qPCR, ddPCR, ELISA & cell-based assays) and excellent method troubleshooting skills, as well as knowledge of various data analysis approaches.
Experience with transferring methods between groups, preferably in a GMP environment.
Self-motivated with excellent organization, time-management, and communication skills
Innovative, critical and creative thinker, not afraid to propose disruptive solutions.
A minimum of one year’s experience in a cGMP environment.
Experience with validation and transfer analytical methods
Experience using Quality by Design principles and have used Design of Experiment approaches for method development/optimization.
Experience in mentoring and managing direct reports
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.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
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