Global Head of Characterization BioAnalytics

Sanofi

Frankfurt am Main, Germany

€ 129,040.00 - €193,560.00 per year

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 - all gernders.

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.

Main 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.

About You

Experience:

• 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.

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 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.

Education:

• PhD in Analytical Chemistry or molecular biology or equivalent.

Languages:

• English fluent.