Job Description
Job Title: Head of CMC Process Standards - Vaccines
Location : Waltham, MA
About the Job
As Head of CMC Process Standards within the Global CMC Process Development and Industrialization (CMC PD&I) function, you will manage a team of SMEs in Quality by Design (QbD) and Process Validation to establish phase-appropriate CMC development and process validation standards, and oversee their deployment in CMC DS and DP sub-teams through CMC Process leaders for new vaccines and non-viral gene therapies from phase 1 to process performance qualification.
We are an innovative global healthcare company committed to helping the world stay ahead of infectious diseases by delivering over 500 million vaccine doses annually. Our talented teams across countries explore new technologies to protect health and promote communities. We pursue scientific breakthroughs daily to make a real impact on millions of patients worldwide.
Main Responsibilities:
CMC Development Standards:
- Develop, adapt, and deploy QbD methodology for CMC workflows and Control Design for CMC DS, DP, and Analytical teams.
- Establish scientific and technological standards related to mRNA CMC platforms for holistic application across cycles 1-3 for new products and genomic medicine projects. Leverage the mRNA platform to streamline deliverables and reduce workload for DS/DP teams, including process control strategies, validations, risk assessments, comparability reports, and dossier filings (IND, CTB, BLA, CTA).
- Collaborate with CMC best practice communities to harmonize, optimize, and standardize development methodologies.
- Contribute to defining source technical documents and standardizing templates and content for dossiers.
Process Validation Management:
- Establish phase-appropriate validation strategies for R&D and manufacturing facilities in partnership with operations and quality teams.
- Manage delivery of validation work packages, reviewing and approving protocols and reports for DS and DP process performance qualifications.
Managerial and Administrative:
- Manage a team of QbD, Process Control Design, and Validation experts.
- Coordinate with global, regional, and local entities including R&D, industrialization, engineering, and digital teams.
- Support the mRNA Center of Excellence (CoE) for new products and CMC platform projects (>50MM).
About You
Qualifications, Education & Experience:
- Master's degree in a related field with at least 8+ years of pharmaceutical industry experience; PhD preferred.
- Extensive experience in vaccine or biologics CMC development from early stages to approval, including mRNA technologies. Strong knowledge of product/process development, cGMPs, and regulatory requirements.
- Proven ability to build relationships at all levels and lead matrix teams.
- Fluency in English required; French language skills are a plus.
- Innovative mindset with the ability to develop new technologies and concepts.
- Strong problem-solving and decision-making skills.
- Excellent interpersonal and communication skills.
Why Choose Us?
- Bring scientific innovations to life with a supportive, future-focused team.
- Opportunities for career growth through promotions or lateral moves, locally or internationally.
- Competitive rewards package recognizing your contributions.
- Comprehensive health and wellbeing benefits, including high-quality healthcare, wellness programs, and at least 14 weeks of parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a diverse workforce. All qualified applicants will receive consideration without regard to race, creed, ancestry, marital or partnership status, gender identity or expression, veteran status, genetic information, or other protected characteristics.
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Compensation will be commensurate with experience. Employees may participate in company benefit programs. Additional benefits information can be found here.
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