Head of CMC Process Standards - Vaccines
Company: Sanofi
Location: Waltham
Posted on: July 8, 2025
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Job Description:
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.
GD-SP LI-SP LI-Onsite 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.
Keywords: Sanofi, Hartford , Head of CMC Process Standards - Vaccines, Science, Research & Development , Waltham, Connecticut
