CMC Project Leader

Job Title:CMC Project LeaderLocation:Framingham, MAAbout The JobAs the CMC Project Lead within our Cluster Mammalian Project team, youll be accountable for the CMC project activities of mammalian projects of Sanofis R&D pipeline from early to late clinical phases up to submission and approval. Ready to get started?Join the engine of Sanofis mission where deepimmunosciencemeets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.About SanofiWere an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.Main ResponsibilitiesThe CMC Project Leader is accountable for the CMC project activities of mammalian projects of Sanofis R&D pipeline from early to late clinical phases up to submission and approval which includes:Lead a cross-functional CMC team with functional members/sub-team leaders from CMC R&D and IA, including Mammalian DS platform, Drug product and formulation platform, Bioanalytics, Device development, Quality, Regulatory CMC, CMC Dossiers, Project Management and Demand & SupplyOversight in CMC and sub teams of approximately 100 to 200 employeesCreate a strategic and integrated CMC development plan based on global project objectivesRepresent the CMC team and function as core member in the Global Project Team, contributing to overall project strategy and execution of the appropriate actions within CMC to achieve project goals.Define the Quality Target Product Profile (QTPP).Act as overall product/process expert for the project and provide technical and scientific expertise on major project topics; drive technical and scientific discussion and alignment within the CMC team and in R&D/M&S cross-functional governance meetingsAccountable for quality of CMC contributions to clinical and PPQ work packages (DS/DP/Analytics), and CMC elements for regulatory submissions and consultations.Drive technical excellence, initiates and oversees CoGs evaluations and align project strategy with commercial expectations.Drive within the CMC team the evaluation of CMC risks and appropriately escalate to Senior Management and provide mitigation plans.Alert decision makers and stakeholders to risks that can impact critical program timelines.Responsible for implementation of CMC deliverables within budget considering external and internal costs.Lead the planning of CMC project budget including communication and alignment with global project team and senior management.About YouBasic Qualifications:Bachelors or masters degree in biotechnology, pharmaceutical engineering, pharmaceutical analysis, biochemistry, chemical engineering or related discipline with a minimum of 16 years of relevant industry experience or PhD with minimum of 12 years of relevant industry experience.Experience in biologics development.CMC regulatory experience in IND filing.Experience in leading international, cross-functional project teams.Expertise in project management and risk assessment.Demonstrated leadership experienceExcellent communication skills; fluency in EnglishPreferred QualificationsExpertise in Biologics CMC area, with proven experience in at least two scientific areas, e.g., analytics, process dev., regulatory CMC, manufacturing, etc.Comprehensive scientific background in biotechnology and/or protein science.Experience working in a matrix organization.Experience and understanding of current Pharmaceutical environment including the economic and regulatory challenges. Experience in BLA submission.Strong leadership capabilities, strong team spirit and capacity to coordinate several activities and stakeholders, excellent communication skills, stakeholder management and networking.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-SA#vhdAll 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.