Principal Research Associate, GMU CMC

Job description

The Principal Research Associate (PRA) will be a part of the Global Drug Product Development & Manufacturing group. The candidate will primarily support and lead Biopharmaceutical Drug Product development projects and workflows for Gene Therapy (in support of the Genomic Medicine Unit) and Protein therapeutic programs. The candidate will have the opportunity to work and lead on different facets of drug product development for different modalities such as gene therapy capsids (recombinant AAV and Lentiviral vectors), Lipid Nanoparticles, Cell Therapy and Protein/Enzyme therapeutics

Key Responsibilities:

·  Lead formulation, process development and stability studies and execute them in multidisciplinary teams.
·  Work with internal and external partners to efficiently and comprehensively address formulation, stability and compatibility aspects using established assays, across a variety of technological platforms and disciplines.
·  Planning, prioritization and initiation of concurrent experimental procedures for multiple programs to ensure their timely completion is essential.
·  Provide technical mentorship to other team members
·  Take ownership of assigned studies to ensure timely completion
·  Maintain a strong work ethic and good documentation practices including electronic laboratory notebook maintenance and writing of technical reports and SOPs
·  Analyze, compile and present results to internal and cross functional teams comprised of members from multiple groups and stakeholders.

Basic Qualifications:

·  Master’s degree in biochemistry, pharmaceutical science, chemical engineering or a related discipline with a minimum of 2 years of relevant industry experience or a Bachelor’s degree with a minimum of 4 years of relevant industry experience
·  Knowledge of analytical and biophysical characterization techniques such as HPLC, CE-SDS, DSC, CD, qPCR, DLS and fluorescence spectroscopy
·  Excellent communication skills.
·  Ability to multi-task and learn new skills and possess flexibility and adaptability that is needed in a fast-paced team environment
·  Excellent teamwork and collaboration skills.

Advanced (or Preferred) Qualifications:  

·  Experience of handing and working with viral gene delivery vectors
·  Knowledge of lyophilization, and process modeling

Applicants must have work authorization in the U.S.

Relocation support is not available for this role.

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.

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