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 inAnalytical 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
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.
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Pursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
