Leading international cross-functional project teams
The CMC Project Leader is accountable for the CMC project activities of mammalian projects from early to late clinical phases up to submission and approval
Job Summary
The CMC Project Leader is accountable for the CMC project activities of mammalian projects from early to late clinical phases up to submission and approval.
You will lead a cross-functional team of approximately 100 to 200 employees across various platforms including Drug Product, Bioanalytics, and Device Development.
Sanofi offers a thoughtful rewards package including high-quality healthcare, prevention programs, and at least 14 weeks' gender-neutral parental leave.
Matching Summary
The CMC Project Leader is accountable for the CMC project activities of mammalian projects from early to late clinical phases up to submission and approval.
Salary
Base: $206,250.00 - $297,916.66; Bonus/Equity: Not specified; Benefits: Eligible for company employee benefit programs
Skills & Requirements
Must-have
16+ years industry experience in biologics
CMC regulatory experience in IND filing
Leading international cross-functional project teams
Expertise in project management and risk assessment
Bachelor's or Master's degree in related discipline
Nice-to-have
Experience in BLA submission process
Proven expertise in at least two scientific areas
Strong stakeholder management and networking skills
Experience working in matrix organization
Understanding of current pharmaceutical economic challenges