Global Head of Characterization BioAnalytics

BioSpace; Framingham (MA); On-site; USD 250,000 - 350,000; Full time

Benefits offered by this job

Health and wellbeing benefits

14 weeks gender-neutral parental leave

Job summary

Sanofi invites applications for Global Head of Characterization, BioAnalytics in Framingham, MA. This role leads a new global organization across sites and countries, reporting to the Global Head of BioAnalytics, CMC Development.

You will steer analytical characterization of biologics during CMC development to manufacturing and transfer to supply. We seek an experienced leader with a PhD in Analytical Chemistry or molecular biology, strong program management, and a track record of transforming

Qualifications

• 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 years' experience in industry including at least 5 years leading an analytical characterization function.

Responsibilities

• Develop and implement a global and comprehensive strategy for extended characterization across all biologics modalities.
• 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.
• Establish and harmonize processes and practices across sites.
• Ensure scientific and operational excellence of teams.
• Transfer high performance analytical methods.

Job description

Job title: Global Head of Characterization, BioAnalytics

• Location: Framingham, 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.

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 Sanofis 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 peoples lives. Were 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 Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi

We're an R&D-driven, AI-powered biopharma company committed to improving people's 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 people's lives.

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

• 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.

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 its 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
• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.