Head of CMC Process Standards

Job Title: Head of CMC Process Standards - Vaccines

Location : Waltham, MA

About the Job

As Head of CMC Process Standards group within Global CMC Process Development and Industrialization (CMC PD&I) function, you will manage a group of Quality by Design (QbD) and Process Validation SMEs to establish phase appropriate CMC development and process validation standards and its deployment in CMC DS and DP sub teams through CMC Process leaders for New Vaccines and non-viral gene therapies from ph1 to process performance qualification.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing Progress to make a real impact on millions of patients around the world.

Main Responsibilities:

CMC Development Standards:

• Responsible to Develop, adapt and deploy Quality by Design (QbD) methodology for CMC development workflows and Control Design to CMC DS, DP and Analytical leaders and CMC sub team members

• Responsible to Establish mRNA CMC platform related scientific & technological standards (Methodology, Process Design workflows...) for holistic application across Cycle 1-3 for New Products and Genomic Medicine Unit projects. Leverage mRNA Platform to rationalize deliverables to reduce drastically workload for DS/DP Products SubTeam for Process Control Strategy, Validations/Verifications (Filter, Process, Cleaning,…) , Risk assessments, Comparability Reports, Dossiers Filling (IND, CTB, BLA, CTA)

• Collaborate with community of CMC best practices to harmonize, optimize and standardize CMC development methodology and best practices

• Contribute to definition of source technical documents for dossier sections preparation and standardization of templates and content

Process Validation Management:

• Establish phase appropriate validation strategies for R&D and M&S facilities in partnership with respective operations and quality functions

• Manage delivery of Process validation supportive work packages from CMC PD&I functions by reviewing and approving validation protocols and reports prepared by MSAT for execution of DS and DP Process Performance Qualification in M&S facilities

Managerial and Administrative:

• Manage a team of QbD, Process Control Design and Validation experts

• Breadth of responsibility (global/regional/country/site): Cooperation with multiple entities global and local (Research & Development, Industrialization, Engineering & Digital teams)

• Supporting mRNA CoE New Products and CMC Platform Project portfolio (>50MM)

About You

Qualifications, Education & work experience:

• Master's degree in related field is the minimum educational requirement with at least 8+ years of experience in the pharmaceutical industry. PhD is preferred.

• Strong experience in vaccine or biologics CMC development from early stage to product approval; mRNA experience preferred included Strong knowledge of product and process development, cGMPs, and regulatory requirements across all stages of product development

• A strong relationship builder at all levels both internally and externally and able to lead a matrix team

• Fluency in English is required. Fluency in French is preferred

• Innovative mindset and ability to develop new technologies and new concepts

• Problem-solver and decision-maker

• Excellent interpersonal and communications skills

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 Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse 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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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.