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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.

Key Responsibilities

• 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.).

Basic Qualifications

• 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.

Preferred Qualifications

• 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.

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.