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Director CMC Lead

2 months ago

cambridge, United States MEDIPOST America, Inc. Full time

MEDIPOST is Korea’s largest and most trusted umbilical cord blood bank and a commercial-stage cell therapy company. We develop novel umbilical cord-derived stem cell therapies to treat degenerative diseases like Alzheimer’s, Diabetic Neuropathy, and Osteoarthritis.


Our flagship product, CARTISTEM, is the world's first allogeneic stem cell therapy for moderate to severe knee Osteoarthritis (OA). Approved in Korea since 2012, over 28,000 patients have been treated with CARTISTEM. We have recently partnered with the Centre for the Commercialization of Regenerative Medicine (CCRM) to form Omniabio, a cell and gene therapy CDMO in Toronto. With our expertise and experience, we are advancing a Phase III clinical program to expand CARTISTEM into North America and Europe.


As we strive to halt degenerative diseases, we seek talented CMC leadership to lead tech transfer to our late-phase and commercial CDMO, manage DP production for our Phase III trials, prepare the CMC strategy for BLA submission, and build a manufacturing organization for commercialization. Reporting to the CEO, the CMC Lead will spearhead CMC strategic planning, execution, and management, preparing CMC submissions for commercial phases. Key responsibilities include:

  • Leading tech transfer to our CDMO
  • Managing DS & DP production for Phase III trials
  • Preparing and executing CMC strategy for BLA submission
  • Building a manufacturing organization for commercialization
  • Partnering with departmental leaders in CMC, Clinical Development, and Regulatory departments


Other Responsibilities:

  • Strengthen cell therapy CMC capabilities with internal and external stakeholders.
  • Integrate inputs into a cohesive CMC strategy.
  • Implement a QBD approach to identify CPPs supporting CQAs.
  • Recruit and develop top talent for the team.
  • Foster a culture of communication, collaboration, and execution.
  • Partner with key functions to achieve CMC and program objectives.
  • Communicate CMC strategy and project status to stakeholders.
  • Provide technical leadership and ensure timely deliverables.
  • Develop and manage a budget with key stakeholders.
  • Lead cross-functional teams for regulatory submissions.
  • Ensure compliance with regulatory, health, safety, and environmental requirements.
  • Manage tech transfer, process familiarization, and manufacturing at CDMOs.
  • Oversee developmental stage-appropriate analytical activities.
  • Develop a vendor selection strategy and manage vendor relationships.


Qualifications:

  • Bachelor’s degree in science, engineering, or related discipline; advanced degree (MS, PharmD, or PhD) preferred.
  • Advanced knowledge and experience in CMC Drug Development for Cell & Gene Therapy.
  • Hands-on knowledge of cGMP and CMC regulatory requirements for cell or gene therapy manufacturing.
  • Six-sigma qualified with experience in QbD and DoE preferred.
  • 10+ years of post-graduate experience leading CMC projects, with at least 5 years in cell therapy manufacturing preferred.
  • Demonstrated leadership in managing teams, projects, and budgets.
  • Experience in late-stage clinical programs, BLA submissions, and commercial manufacturing preferred.
  • Experience with drug-device combination products preferred.
  • Previous experience with CGT CDMOs is a plus.
  • Excellent interpersonal and communication skills.
  • Strong organizational skills and ability to work in a multicultural environment.
  • Ability to motivate teams and deliver on milestones.
  • Strong analytical and problem-solving skills.
  • Proven success in goal setting, resource planning, and budget management.
  • Flexibility and comfort with ambiguity.
  • Travel Requirements:25% to 40% travel as needed.


Join MEDIPOST and play a pivotal role in revolutionizing healthcare through cutting-edge cell therapy solutions.