Analytical Sciences Director

Sanofi•Cambridge, MA

7d•$178,500 - $257,833•Hybrid

About The Position

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.

Requirements

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 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
Solid understanding of CMC aspects of drug development and related functions, including chemistry, physical quality and formulations
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
Languages: English

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
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
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
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
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