Head of mRNA Bioassay, Associate Director - Vaccines

Sanofi • Waltham, MA

3d • Onsite

About The Position

Sanofi Pasteur is seeking a dynamic and driven leader to head a 10+ person Bioassay group within the US mRNA analytical development, Analytical Sciences Department. In this role, you will spearhead the development and characterization of cutting-edge mRNA vaccine analytical methods, working in close collaboration with the Bioprocess Development team. You will play a pivotal role in advancing the qualification and validation of robust analytical methods that support the release and characterization of mRNA Drug Substances and Drug Products — directly contributing to the future of vaccine innovation.

Requirements

• PhD or MSc/degree in Cell biology, Biology, Microbiology or related sciences
• PhD with 8+ years or MSc with at least 12+ of pharma/biotech industry experience, skilled in analytical bioassays.
• Demonstrated people and project leadership skills
• Ability to perform complex method development and propose appropriate method improvement
• Knowledge of nucleic acid/oligonucleotides chemistry and standard analytical methods of these molecules
• Experience in various biological and bioanalytical assays, including cell-based western blot, sanger sequencing, high throughout sequencing, ELISA, qPCR, ddPCR, endotoxin and microbiology assays, binding assays, kinetic assays, etc.
• Thorough understanding of analytical technology and relevant statistical methods.
• Proven capability of evaluating/developing new technologies
• Excellent organizational skills
• Significant amount of regulatory knowledge and guidance in cGMP, ICH, USP, etc.
• Able to work independently and collaborate in teams, enthusiastic and self-motivated

Responsibilities

• Lead the analytical development Bioassay team to support all analytical CMC activities for mRNA-based vaccine and drug development from Phase 1 to phase 3, including but not limit to process development, analytical release stability and characterization testing, CRO management, documentation management, and regulatory submission, etc.
• Represent the Analytical Science group in CMC teams.
• Plan, initiate, and direct the overall scientific activities for new projects including new technological ideas; engage in bench laboratory work when appropriate.
• Set the scientific standards; develop and author complex, explicit documentation for new and current procedures, validation protocols and technical reports incorporating appropriate use of statistics.
• Stay current with regulatory guidance for vaccine and biological drug development and serves as a thoughtful leader and internal expert in dealing with regulatory commitments and responses.
• Initiate complex projects which have significant scientific risk and applies strong scientific risk assessment skills.
• Develop innovative and relevant solutions to extremely complex problems.
• Make critical contributions to scientific literature and conferences and is recognized internally and externally at national and international levels.
• Oversee analytical method development, qualification, validation, and transfer.
• Identify potential problems and proactively suggest technical solutions based upon analytical expertise and knowledge of product/process.
• Function in a project leadership role, guiding the successful completion of major projects to meet the projected timeline.
• Participate in project strategy in consultation with supervisor and/or colleagues.
• Lead the analytical CMC section writing for regulatory submissions and responses.
• Work under consultative direction toward long-range goals and objectives. Assignments are often self-initiated.
• Represent the organization in providing solutions to difficult technical issues associated with specific projects.
• Interact with senior external personnel on significant technical matters often requiring coordination between organizations.
• Serve as organization spokesperson on advanced projects and/or programs.
• Act as advisor to management and/or customers on advanced technical research studies and applications.
• Manage and direct the work of analysts and scientists.
• Act as role models for our fellow employees by acting responsibly, fairly, and honestly in dealings and exercise sound judgment in performing jobs.
• Motivate, inspire, build, and retain highly effective team while managing for high performance and developing others.

Benefits

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree