Sanofi Group CMC Project Leader Genomic Medicine - Framingham/Waltham in Framingham, Massachusetts
Strategy development, planning and timely implementation for all CMC related functions for gene/cell therapy programs from early phase clinical development through commercial launch
Lead an integrated CMC team of drug substance/drug product manufacturing, quality, regulatory, and supply chain subject matter experts.
Participate as a core team member on the Global Project Team contributing to the program strategy by representing CMC
Provide consolidated recommendations to the Global Project Team and execute the appropriate actions within CMC to achieve project goals
Define the Quality Target Product Profile (QTPP) according to TPP
Responsible for quality of CMC contributions to pre-clinical, clinical and validation (DS/DP), and CMC elements for regulatory submissions and consultations
Evaluate 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 local department heads & global functions as needed.
Responsible for implementation of CMC deliverables within budget considering external and internal costs.
Bachelor’s or master’s degree in biotechnology, pharmaceutical engineering or natural sciences or related discipline with a minimum of 14 years of relevant experience or PhD with minimum of 10 years of relevant 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
Experience in the field of gene/cell therapy or vaccines
Working knowledge in one or more of the following areas: molecular and cell biology, biochemistry, cell culture manufacturing, purification process development, and Bioanalytics
Experience in BLA submission
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.