Global Head of Characterization BioAnalytics

Sanofi•Framingham, MA

9d•Hybrid

About The Position

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. We are seeking a highly motivated and skilled Global Head of Characterization, BioAnalytics. In this position, you will lead a new global organization consisting of groups based across multiple sites and countries and report directly to the Global Head of BioAnalytics, CMC Development. You will be responsible for analytical characterization of therapies across all of Sanofi’s biologics modalities during CMC development to commercialization and transfer to Manufacturing & Supply. This will include strategic positioning of BioAnalytics in CQA definition during CMC development. You will drive strategy and operations during the development projects of new biologic entities, providing technical 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? 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.

Requirements

Broad and long-term experience in extended characterization of large molecules with strong knowledge of late phase development
Proven track record in driving transformative organizational changes and sustained, effective change management
At least 15 year-experience in industry including at least 5 years leading an analytical characterization function.
Able to lead & animate highly scientific teams, experts
Excellent communication and interpersonal skills, stakeholder management skills
Ability to manage a large global 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 extended characterization
Familiarity with digitalization and evolution of AI in CMC
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 acting as an analytical team leader for a development project
Advanced scientific network within Academia and Industry
Track record of publications and patents
PhD in Analytical Chemistry or molecular biology or equivalent.
English fluent.

Responsibilities

Develop and implement a global and comprehensive strategy for extended characterization across all biologics modalities including antibodies, nanobodies, multispecifics, and gene therapy modalities (viral and nonviral)
Oversee resource allocation, budgeting, and forecasting across multiple sites to enable efficient, timely, and effective support for a broad and complex pipeline
Focus on team building across sites, talent development, and developing a pipeline of future leaders with strong technical expertise and business acumen
Definition of CQAs with line of sight to both analytical control strategy and an integrated control strategy
Partner and collaborate with the BioA leadership and across CMC to prioritize work and ensure timely deliverables
Establish and harmonize processes and practices across sites.
Ensure scientific and operational excellence of teams.
Innovate on advanced analytical platforms with broad application to the portfolio
Ensure high scientific level for analytical sections of CMC dossiers
Transfer high performance analytical methods