Senior Director, Process Development

4 weeks ago


Toronto, Ontario, Canada BlueRock Therapeutics Full time
Job Summary:

BlueRock Therapeutics is seeking a highly experienced Senior Director, Process Development to lead the development of manufacturing processes for our cutting-edge cellular therapies. As a key member of our Process & Analytical Development organization, you will oversee the development of phase-appropriate manufacturing processes, ensuring quality compliance and regulatory requirements are met. This is an outstanding opportunity to contribute to the advancement of cellular therapies and build a sustainable organization.

Responsibilities:
  • Lead the process development team to develop, optimize, scale-up, and troubleshoot manufacturing processes for authentic and engineered cellular products.
  • Provide technical oversight, scientific leadership, and career development expertise to a diverse team of process development team members.
  • Collaborate cross-functionally with senior leaders to ensure a thorough understanding of the requirements for the manufacture of iPSCs and derivatives in a cGMP compliant manner.
  • Author and/or review CMC sections of IND/INDa/BLA and respond to regulatory inquiries.

Requirements:
  • Advanced degree in biological engineering, chemical engineering, biological sciences, or similar with 12+ years' experience in industry with focus on advanced therapeutic modalities, including cell therapies.
  • Proven cross-functional leadership capabilities with seasoned experience in people management, organizational design, and technical oversight.
  • Exceptional communication skills, engaging effectively at all levels of the company and externally to partners and vendors.
  • Hands-on experience in the development of cell therapies, ideally including pluripotent stem cells and differentiation thereof, bioprocess development for cell banks, Drug Substance, and/or Drug Product.


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