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 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.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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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Pursue progress , discover extraordinary

Better 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.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

North America Applicants Only

The salary range for this position is:

$178,500.00 - $257,833.33

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK .