Senior Director of CMC Technical Innovation

3 weeks ago

Cambridge, Massachusetts, United States Proclinical Staffing Full time
Senior Director CMC Technical Innovation

Proclinical Staffing is seeking a seasoned professional to lead our Technical Operations team in Gene Therapy development. As a Senior Director of CMC Technical Innovation, you will drive technical innovation, enhance our capabilities, and maintain our position as a world leader in the industry.

Key Responsibilities:
  • Establish a centralized innovation framework to drive implementation of new technology and streamline IP engagement
  • Expand our Technical Operations presence through publications, speaking engagements, and industry consortiums
  • Screen, analyze, and negotiate potential technical collaborations from a scientific, financial, and strategic perspective
  • Drive identification and enablement of novel technologies and cross-functional Technical Operations improvements
  • Serve as the liaison to Technical Operations scientific and business teams to provide proposals to senior leadership and prioritize innovation in alignment with the organizational and Technical Operations strategy
  • Demonstrate influential leadership capabilities and foster a collaborative team environment
  • Lead organizational initiatives and represent Technical Operations on behalf of the organization
  • Participate in project-related teams and other internal/external collaborations to support the client's objectives
Requirements:
  • Bachelor's degree in Life Sciences or Engineering with 15+ years of relevant experience and 5+ years in a leadership role. Advanced degree preferred.
  • Experience in end-to-end CMC drug development from early to late-stage development, GMP clinical and commercial operations, and regulatory submissions
  • Proficient in GMP, GLP, and regulatory guidelines related to pharmaceutical development
  • Excellent communication and interpersonal skills to help build strong relationships across scientific and business functions
  • Extensive experience with the process and principles of development, technical transfer, scale-up design, drug substance/drug product unit operations, and analytical methods
  • Excellent listener, seeks broad input and feedback, provides frequent and effective follow-up
  • Solid understanding of statistical design and modeling of experiments
  • Experience leading negotiations and executing agreements (e.g., material, license, etc.)
  • Must have effective written and verbal communication skills

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