Project Leader CMC, Mammalian Projects
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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 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/IA 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.
Bachelor’s or master’s degree in biotechnology, pharmaceutical engineering, pharmaceutical analysis, biochemistry, chemical engineering 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 leadership experience
Excellent communication skills; fluency in English
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.
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 R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
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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