Sanofi
Biopharma
CMCProjectLeader
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“CMC Project Leader at Sanofi. Skills: CMC Project Leader, Biologics development, Project management. Lead cross-functional CMC team. Oversight in CMC and sub teams”
What You'll Achieve.
Achieve project goals; Submission and approval; Align project strategy with commercial expectations
Industry & Context.
What They're Looking For.
Must Have
Bachelor's or master’s 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 experience, Excellent communication fluency in English
Nice to Have
Expertise 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, leadership capabilities, team spirit and capacity to coordinate several activities and stakeholders, excellent communication skills, stakeholder management and networking
What You'll Do.
Lead cross-functional CMC team
Oversight in CMC and sub teams
Create strategic and integrated CMC development plan
Represent CMC team in Global Project Team
Define Quality Target Product Profile
Provide technical and scientific expertise
Accountable for quality of CMC contributions
Drive technical excellence
Drive evaluation of CMC risks
Alert decision makers to risks
Responsible for implementation of CMC deliverables
Lead planning of CMC project budget
How You'll Work.
Team & Collaboration
Lead a cross-functional CMC team; Represent the CMC team and function as core member in the Global Project Team; Drive technical and scientific discussion and alignment within the CMC team; Coordinate several activities and stakeholders
Communication Scope
Excellent communication fluency in English; Excellent communication skills
Process & Methodology
Project management, Risk assessment, Project budget planning
Full Job Description
**Job Title:** CMC Project Leader **Location: **Framingham, MA **About the Job** As the CMC Project Lead within our Cluster Mammalian Project team, you’ll be accountable for the CMC project activities of mammalian projects of Sanofi’s R&D pipeline from early to late clinical phases up to submission and approval. Ready to get started? Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. **About Sanofi** We’re an R&D-driven, AI-powered biopharma company committed to improving people’s 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 people’s lives. ** _Main Responsibilities:_** The CMC Project Leader is accountable for the CMC project activities of mammalian projects of Sanofi’s 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 & Supply * Oversight in CMC and sub teams of approximately 100 to 200 employees * Create a strategic and integrated CMC development plan based on global project objectives * Represent 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 discus
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