CMC Project Leader Mammalian Projects
Framingham, Massachusetts, Vitry-sur-Seine, France
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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 & formulation platform, Bioanalytics, device development, Quality, Regulatory CMC, CMC dossiers, and supply chain as well as IA representatives from commercial manufacturing and/or MSAT. He/she has an oversight in CMC and subteams of approximately 100-200 FTEs.
Creates a strategic and integrated CMC development plan based on global project objectives ensuring alignment with base case and accelerated plans and exploring opportunities for acceleration.
Represent the CMC team and functions (including IA topics) as core member in the Global Project Team, contributes to overall project strategy and executes the appropriate actions within CMC to achieve project goals. Following the TPP, he/she defines the Quality Target Product Profile (QTPP).
Acts as overall product/process expert for the project and provides technical and scientific expertise on major project topics, drives and leads technical and scientific discussion and alignment within the CMC team and in R&D/IA cross-functional governance meetings (Technical Review meetings, CMC Boards, DWG, IDCC).
Responsible for quality of CMC contributions to clinical and PPQ workpackages (DS/DP/Analytics), and CMC elements for regulatory submissions and consultations. He/she drives technical excellence, initiates and oversees CoGs evaluations and align project strategy with commercial expectations.
Drive the evaluation of CMC risks and appropriately escalate to Senior Management (e.g. Sponsor & Global Management as needed) and Global Project Team (Project Direction) and proactively provides mitigation plans.
Alert decision makers and stakeholders to risks that can impact critical program timelines. In case of scientific/technical issues, coordinate corrective measures across functions in cooperation with all relevant site and department heads and global functions as needed.
Responsible for implementation of CMC deliverables within budget considering external and internal costs. He/she leads and oversees planning of CMC project budget including communication and alignment with global project team and senior management.
Bachelor’s or master’s degree in biotechnology, pharmaceutical engineering or natural sciences or related discipline with a minimum of 14 years of relevant industry experience or PhD with minimum of 10 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 strong leadership experience and excellent communication skills.
Ability to work in a matrix organization.
Strong expertise in Biologics CMC area, with proven experience in at least 2 scientific areas, e.g., analytics, process dev., regulatory CMC, manufacturing, etc.
Comprehensive scientific background in biotechnology and/or protein science.
Experience and understanding of current Pharmaceutical environment including the economic and regulatory challenges. Experience in BLA submission.
Confirmed experience in project management, in working in project team and in complex environment (e.g., transversal assignments across different sites).
Fluent in English.
Strong leadership capabilities, strong team spirit and capacity to coordinate several activities and stakeholders, excellent communication skills, stakeholder management and networking.
Experience in leading international and/or multi-cultural teams.
Influencing and negotiation skills to build solutions and partnership.
Objectives and deliverables / results oriented. Capable to deliver under high pressure.
Ability to interact effectively with executive/senior management and external bodies (e.g., auditors, health authorities, etc.).
Take responsibility for decisions and accountable for results.
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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