Analytical Sciences Director

Within R&D, Synthetics CMC Development at Sanofi is responsible for all aspects of synthetic/small molecule drug development, from candidate selection to product approval. This encompasses drug substance (DS) and oral drug product (DP) development, Analytical Sciences, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission to NDA approval. Our mission is to serve patients through relentless innovation in synthetic drug development and by designing state‑of‑the‑art manufacturing processes.

To this end, our development model is focused on speed to clinic for early‑stage programs and delivering safe, robust, and eco‑designed late‑stage and commercial processes.

Responsibilities:

• 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

Key Activities:

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

• Lead the Digital Transformation within the organization

• Represent the company in internal and external forums

Scientific

• Lead 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

• Ensure the 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

People

• Manage transversely a dynamic Analytical Sciences team

• Act as a role model for the management essentials through appropriate managerial attributes and behaviors

• Promote clear decision making, coaching and feed-back

• Attract, hire, maintain, and motivate high quality working force

• Develop, coach, and empower team members to promote a high degree of personal accountability, successful teamwork and leadership skills. Serve as key scientific representative for Analytical Sciences, and to support rapid decision-making on projects

Qualifications:

• BS in Analytical Chemistry or related field with at least 14 years of relevant experience within the pharmaceutical industry OR

• MS 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…