Principal Research Associate Bioanalytics
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Sanofi is seeking a highly motivated Principal research Associate to join the Analytical Development team in our growing Genomic Medicines Unit (GMU) in Waltham, MA. The GMU Analytical 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 simple and complex molecular methods and bioassays, method qualifications, GMP testing, and validation activities. In addition, the 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 little 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 with a minimum of 2 years of relevant industry experience, or a Bachelor’s Degree in Biology/Biochemistry or related discipline and with a minimum of 4 years of relevant industry experience.
Experience using and developing molecular techniques such as qPCR or ddPCR, or bioassay development.
Basic understanding molecular procedures and technologies with proven ability to interpret and present data.
Understanding of MOA for protein, antibody and gene therapy-based therapeutics.
Experience with PCR, ELISA, western blotting, cell-based potency assays, and affinity/ligand platforms such as surface plasmon resonance.
Familiarity with software packages to analyze dose-responses and statistical analysis (SoftMax, JMP, etc).
Familiar with QbD principles and DOE approaches for method development and optimization.
Working experience in GMP environment will be considered an advantage.
Experience with validation and transfer analytical methods
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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