Associate Director, External Manufacturing

1 week ago

Philadelphia, Pennsylvania, United States InsideHigherEd Full time

About the Role:

The Gene Therapy Program at InsideHigherEd is seeking a highly experienced Associate Director, External Manufacturing to lead the development of external Chemistry Manufacturing Control (CMC) project plans for our programs. As a key member of our team, you will be responsible for developing and implementing strategies to ensure the successful transfer of our products to Contract Manufacturing Organizations (CMOs).

Key Responsibilities:

  • Develop and lead the interaction of the CMC cross-functional projects among our personnel, and between our organization and the CMOs.
  • Travel to CMOs during campaign launches and throughout the campaign as needed to monitor and manage CMC process transfer, supply chain, budgets, and ensure project milestones and timelines are being met from early to late stage production at CMO.
  • Create and maintain comprehensive risk management plans for product production to minimize the impact of obstacles to overall campaign goals.
  • Collaborate with our cross-functional teams to ensure seamless integration of CMC aspects into our overall development strategy.
  • Develop and maintain strong relationships with our CMO partners to ensure successful project execution.

Requirements:

  • Master's degree in Chemical or Biomedical Engineering or similar field with 5-7 years of experience with processes to make biologics, viral vectors, or vaccines or an equivalent combination of education and experience.
  • Experience with planning and managing CMC aspects of biopharmaceutical development.
  • Experience in process development (including design of experiments, DOE) and process transfer, focused on biologics, viral vectors, or vaccines.
  • Experience in CMO search, selection, and management.
  • Experience in person in plant (PIP) for production of biopharmaceutical products.
  • Ability to travel (domestic % of the time, particularly when production campaigns are being done).
  • Excellent communication skills, with the ability to provide clear, audience-focused descriptions of CMC tasks and issues, and proposed solutions to schedule challenges.
  • Demonstrated ability to facilitate project team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal (and sometimes external) stakeholders.
  • Familiar with current issues and Regulatory requirements related to manufacturing using single-use equipment for drug substance and drug product production.
  • Familiar with trends and developments in the gene therapy field and able to translate those developments into specific business advantages and risks related to production.
  • Proficiency with Microsoft Office suite (e.g. Word, Excel, PowerPoint, Project, Outlook) and Visio and JMP or similar.
  • Valid driver's license.

What We Offer:

  • A competitive salary and benefits package.
  • The opportunity to work with a dynamic team of professionals in the gene therapy field.
  • A collaborative and supportive work environment.
  • The chance to make a meaningful contribution to the development of innovative gene therapies.

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