Analytical Sciences Director

BioSpace; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Healthcare benefits

Parental leave (14 weeks)

Wellbeing programs

Job summary

Sanofi US Services in Cambridge is seeking a senior leader for Analytical Sciences within the Synthetics CMC Development group. You will lead a transdisciplinary team, drive strategy for analytical sciences, and push innovations in process chemistry support, stability studies, and regulatory dossier preparation.

The role requires a PhD/ MS/BS with extensive pharma experience, strong GMP/ICH knowledge, and the ability to coordinate across R&D, DS/DP, and regulatory teams to deliver cutting-edge,

Qualifications

• BS in Analytical Chemistry or related field with at least 14 years of relevant experience within the pharmaceutical industry.
• MS Analytical Chemistry or related field with at least 12 years of relevant experience within the pharmaceutical industry.
• 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 (CTD).
• Strong scientific track record in analytical sciences in R&D and GMP knowledge.
• Languages: English.

Responsibilities

• Lead transversely the analytical sciences team at the Cambridge Crossing site.
• Develop and apply analytical strategies to drive in-class R&D programs.
• Design, develop and apply analytical technologies.
• Drive analytical sciences innovation and digital transformation within the organization.
• Develop the people and the organization in line with the Take The Lead strategy.
• Interface with key partners to deliver pipeline and projects.
• Oversee regulatory dossier preparation and CTD submissions.

Skills

English

Education

BS in Analytical Chemistry or related field

MS Analytical Chemistry or related field

PhD in Analytical Chemistry or related field

Job description

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 SanofisFirst in Class and Best in Class R&D programs
• Design, develop and apply analytical technologies
• Drive analytical sciences innovation according to our laboratorys digitalization and automation road map
• Develop the people and the organization in line with Sanofis 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 formation 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 its 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.

#GD-SP

#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.