Cmc Project Leader

Sanofi Genzyme

Framingham, MA, US
Base: $206,250.00 - $297,916.66; bonus/equity: not...
Onsite
16 years industry experience or phd with 12 years
Experience in biologics development
Cmc regulatory experience in ind filing
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 including members from CMC R&D, Quality, Regulatory, and Project Management.
  • 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 or PhD with 12 years
  • Experience in biologics development
  • CMC regulatory experience in IND filing
  • Leading international cross-functional project teams
  • Expertise in project management and risk assessment

Nice-to-have

  • Experience in BLA submission
  • Proven expertise in at least two scientific areas
  • Experience working in a matrix organization
  • Strong stakeholder management and networking skills
  • Understanding of current pharmaceutical economic challenges

Key Requirements

  • Bachelor's or Master's degree in biotechnology or related field
  • Minimum 16 years relevant industry experience
  • PhD with minimum 12 years relevant industry experience
  • Fluency in English required

Work Rights

Not specified

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