Analytical Sciences Director

Sanofi · Cambridge, MA · 1 mo ago

HybridFull-time

Responsible for all analytical sciences activities related to Synthetic / Small Molecules and Solid Oral Dosage Forms at the Cambridge Crossing site
Develop and apply advanced analytical strategies to drive Sanofi’s First in Class and Best in Class R&D programs
Design, develop and apply analytical technologies
Drive analytical sciences innovation according to our laboratory’s digitalization and automation road map
Develop the people and the organization in line with Sanofi’s Take The Lead strategy

Strategic: Participate in the strategic evolution for Analytical Sciences in-line with the Synthetics Platform and Global CMC Development strategy and project needs
Interface with key partners (within CMC, R&D and M&S, and Research Platforms) as needed to deliver the pipeline & projects
Promote a “one-team” culture among scientists in DS, DP, Analytics and clinical dossier preparation and development
Represent the company in internal and external forums
Scientific: Transversely the analytical sciences team
Drive the analytical sciences activities related to process chemistry support, pre formulation support, control strategy development, stability studies for intermediates, starting materials, drug substance and drug product in all stages of development
Propose constant upgrading of analytical technologies to offer technical innovations and to generate intellectual property
Scan the external environment to anticipate potential opportunities and to evaluate scientific and technological collaborations relevant to state-of-the-art analytical development
Operational: Ensure resources are allocated to deliver on projects according to the defined priorities
Transversal analytical support to other CMC Synthetics function
Propose proper analytical training and new technologies for the development
Oversee outsourced activities when applicable (applying outsourcing strategy defined by the CMC Platform) and know when to internalize activities
Review and approve Scientific documents

BS in Analytical Chemistry or related field with at least 14 years of relevant experience within the pharmaceutical industry
OR
MS in Analytical Chemistry or related field with at least 12 years of relevant experience within the pharmaceutical industry
OR
PhD in Analytical Chemistry or related field with at least 10 years of relevant experience within the pharmaceutical industry.
At least 3+ years demonstrated people management and leadership experience
Strong knowledge of pharmaceutical regulatory requirements (ICH guidelines, EMA/FDA regulations, and international standards)
Proven experience in clinical trial documentation and regulatory dossier submission
Strong scientific track record in analytical sciences in R&D
Advanced scientific network within academia and industry
Ability to align resources and management, execute and adapt as needed to achieve short and long-term goals
Experience in managing teams of high-level scientists
Strong knowledge in GMP, ICH requirements, pharmacopoeia
Demonstrated experience in clinical dossier and CTD submissions
Demonstrated technical, and organizational skills; ability to work in a matrix organization
Show initiative and creativity in proposing, developing and executing ideas
Encourage experimentation, educated risk taking and learning from failure

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

Similar jobs