Senior Scientist Bioassay Development and Quality Control

Location: Waltham, MA

About the role

Opportunity to join a fast-paced Gene Therapy bioanalytical team focusing on potency method development, qualification, QC testing and CRO transfer in a compliant GMP environment. This position will improve analytical capacity for the potency team, allowing more programs to progress efficiently through early phase development. The successful candidate will be responsible for method development for multiple viral and non-viral gene therapies through hands-on work including method development and optimization, SOP and report writing and providing group presentations. This is a great opportunity for an energetic and dedicated team player willing to do what it takes to support our goal of releasing critical medicines to patients. Join the engine of Sanofi's mission where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. Sanofi is an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

Responsibilities

• Responsible for early-stage GMP release testing and maintaining a GMP compliant environment.
• Serve as a subject matter expert (SME) for biological potency assays for viral and non-viral products, define the best scientific approaches and analysis methods for quantitative bioassays.
• Development, qualification and validation and transfer of analytical methods.
• Master Sanofi quality systems providing expertise and coaching to team members.
• Perform analytical support testing, ensuring timely completion and delivery of analytical results with appropriate documentation to support product development during clinical phases.
• Participate in analytical leadership teams for viral and non-viral programs.
• Take an active role in Lab maintenance, organization, GMP and safety compliance.
• Ensure compliant use of electronic notebooks.
• Work in a matrixed environment and interact productively with associates, scientists and management at various levels, both locally and internationally.