Job title: Head of Bioanalytics GMU
Grade: L5-1
Hiring Manager: Laurent Duhau
Location: Waltham, MA
About the Job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
Within Sanofi R&D, Global CMC Development is a key enabler of Sanofi's growth aspiration through its mission to develop manufacturing processes, formulations, and analytical methods for new clinical drugs.
Global BioAnalytics provide strong, science-based and quality-driven analytical value for all biologics modalitiesby ensuring comprehensive understanding of our products and processes using state of the art technologies.
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We are seeking a highly motivated and skilled CMC BioAnalytics Gene Therapy site head.
In this position, you will lead a group of approximately 60 scientists and will ensure the analytical development of new Gene (Viral/Non-Viral) biologics therapies from transition to research up to commercialization and transfer to Manufacturing & Supply. You will contribute strategically and operationally to the development projects of new biologic entities as functional head, providing strategic inputs and resources as well as securing the project deliverables.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
- Ensure appropriate analytical control strategy for new gene therapy modalities
- Ensure analytical development & quality control activities to guarantee quality of products used in clinical trials
- Ensure state of the art molecule characterization & understanding
- Ensure operational excellence of teams.
- Ensure high scientific level for all analytical sections of CMC dossiers
- Transfer high performance Analytical Methods to M&S
- Attract, hire, maintain, and motivate high quality working force
Experience:
- Broad and long-term experience in the analytical development of Biologics with expertise in Gene therapy and strong knowledge of late phase development.
Soft and technical skills:
- Able to lead & animate highly scientific teams, experts - Excellent communication and interpersonal skills, stakeholder management skills
- Ability to manage a large organization with strong operational excellence
- High level of autonomy. Executes, comfortable with ambiguity,and adapts with agility.
- Demonstrated technical, project management and organizational skills; ability to work in a matrix organization
- Issue resolution and decision-making skills
- Structured, goal-oriented and highly motivated
- Ability to deliver results under high pressure
- Strong and proven ability to work transversally on a local and global level
- Strong scientific track record in analytical development of gene therapy products
- Solid understanding of CMC aspects of biological drug development and related functions, including process development and formulation development
- In depth understanding of Quality by Design principles & ICH guidelines
- Experience of global submissions (NDA, MAA) and approval and interactions with regulatory agencies.
- Experience with GMP audits.
- Experience acting as an analytical team leader for a development project
- Advanced scientific network within Academia and Industry
- Track record of publications and patents
Education:
- PhD in Analytical Chemistry or molecular biology or equivalent.
- At least 15 year-experience in a similar position (Pharma Industry) including at least 3 years on gene therapy (viral & non-viral)
Languages:
- English fluent.
Why Choose Us?
- 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.
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.