Sanofi Group Senior Research Associate, Genomic Medicine Bioanalytics in Framingham, Massachusetts
We are seeking an energetic and highly motivated Senior Research Associate to join the newly formed Bioassay and Molecular (BAM) Analytical Development group within the Genomic Medicine Unit (GMU), located in Framingham, MA. The GMU Bioanalytical Development 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 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, perform compendial verifications, 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.
Plan, prioritize and execute simple and complex experiments with the relevant controls with minimal guidance from their supervisor.
Integrate, compile, analyze, and interpret data with minimal supervision.
Write simple technical reports & SOPs, including clear and concise technical data presentation and discussion.
Perform cGMP sample testing, following method protocols (SOPs), and generate data packets for results.
Work within a broader team to support the development and implementation of new ways of working and methodologies.
Ensure timely completion and delivery of analytical results and documentation (ELN, technical reports, SOPs, etc.).
Master’s degree in Biology/Biochemistry or related discipline or Bachelor’s degree with a minimum of two years of relevant experience in the Biotechnology/pharmaceutical industry.
Experience using and developing molecular techniques such as qPCR or ddPCR, or bioassay development.
Basic understanding molecular procedures and technologies.
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.
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.
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.
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