CMC Project Leader

Sanofi•Framingham, MA

6d•Onsite

About The Position

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.

Requirements

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 skills; fluency in English

Nice To Haves

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.
Strong leadership capabilities, strong team spirit and capacity to coordinate several activities and stakeholders, excellent communication skills, stakeholder management and networking.

Responsibilities

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 discussion and alignment within the CMC team and in R&D/M&S cross-functional governance meetings
Accountable 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.