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Analytical Development Director

AT Sanofi U.S.
Sanofi U.S.

Analytical Development Director

Gunnison, CO

Job Title: Analytical Development Director

  • Location: Cambridge, MA

About the Job

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?

Sanofi is seeking an Analytical Development Director to lead the analytical group in our CMC function at Cambridge Crossing site, which is part of the synthetic platform within Global CMC Development. We are striving to become an industry leader in the development of transformative medicines. Formed by highly skilled scientists and equipped with state-of-the-art instruments, this analytical group has the responsibility to support projects in all clinical phases up to market launch of innovative therapies.The endeavor to transform Sanofi R&D's portfolio of products in development, as well as the maintenance of our competitiveness and scientific excellence are the drivers for our continuous improvement over the coming years. The successful candidate will be a team leader that has the experience and skills to motivate our employees to accomplish our mission.

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Job Responsibilities
  • You will be responsible for all analytical development activities related to small molecules and solid oral dosage forms at Sanofi's Cambridge Crossing site
  • Lead the analytical team to provide support for studies including solubility, pre-formulation, control, intermediate stability, starting material, drug substance and drug product in all stage of development
  • Ensure adequate analytical support to groups in pharmaceutical science, process chemistry and process engineering
  • Ensure proper resource allocation to deliver on projects according to the defined priorities
  • Writing and reviewing technical and scientific documents, including protocols and reports, validation documents, regulatory submissions, and test methods
  • Ensure timely generation of analytical sections of the CMC documents
  • Interface effectively with peers within CMC, Manufacturing and Research Platform to deliver on projects
  • Develop and apply advanced analytical strategies to drive Sanofi'sFirst-in-Class and Best-in-Class R&D programs
  • Contribute to the Digital Transformation within the organization
  • Represent the group in internal and external forums
  • Oversee outsourced activities following the outsourcing strategy defined by the CMC Platform
  • Generate CAPEX proposals to ensure the equipment and practices in the group remain state-of-the-art
  • Promote a "one-team" culture among scientists in DS, DP, Analytics and clinical dossier preparation and development
  • Keep abreast of the evolution and innovation in the analytical technology landscape and drive internal innovations
  • Attract, hire, maintain, and motivate a high-performance working force.Act as a role model and develop the people and the organization in line with Sanofi's Play to Win strategy.

About you

Basic Qualifications
  • Masters degree or equivalent in Analytical Chemistry or related field with a minimum of 10 years working in the pharmaceutical industry. PhD in Analytical Chemistry is preferred
  • Demonstrated success in managing high performance analytical development teams
  • Demonstrated ability to manage resources to achieve short and long-term goals
  • Having a solid understanding of CMC related functions and activities in drug development
  • Proven track record of showing initiative and creativity in problem solving
  • Demonstrated ability to work in a matrix organization
  • Excellent communication skills and technical writing skills
  • Having a strong record in scientific publications and patents
  • Having an advanced scientific network in the academia and industry

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.

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Client-provided location(s): United States
Job ID: Sanofi-https://jobs.sanofi.com/en/job/cambridge/analytical-development-director/2649/16949511744
Employment Type: Other