Executive Director, Head of Drug Substance

Company: Apex Systems
Location: Boston
Posted on: April 1, 2025

Job Description:

Executive Director, Head of Drug SubstanceExecutive Director, Head of Drug Substance 2066884Focus: BiologicsJob Overview: Seeking a Head of Drug Substance to spearhead drug substance development, drive strategy, manage teams, and collaborate across functions in a pharmaceutical leadership role.Primary Job Responsibilities:

• Guide drug substance development from preclinical to commercial stages.
• Strengthen strategic partnerships with CDMOs for drug development advancement.
• Manage the creation and oversight of regulatory documents and inquiries.
• Collaborate across departments to streamline drug development processes.
• Represent the Pharmaceutical Sciences division internally and externally for strategic activities.
• Control the budget for drug substance manufacturing and development.Primary Job Requirements:
  • Ph.D. or BS/MS with extensive bioprocess development experience, specializing in cell line and upstream process development.
  • Require at least 5 years of management experience with strong leadership in strategic team development.
  • Proven track record in building strong relationships with stakeholders and CDMO partners.
  • Deep understanding of regulatory and compliance frameworks related to drug substance development.
  • Highly collaborative with strong interpersonal skills, ensuring effective team and stakeholder interactions.
  • Excellent communication skills, adept at presentations and information dissemination.
  • Ability to travel 25% of the time, both domestically and internationally.
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Keywords: Apex Systems, Boston , Executive Director, Head of Drug Substance, Executive , Boston, Massachusetts