Vice President of Process Development

2 months ago

Toronto, Ontario, Canada BlueRock Therapeutics Full time
About BlueRock Therapeutics

BlueRock Therapeutics is a pioneering engineered cell therapy company that leverages its unique cell+gene platform to develop innovative cellular medicines for patients suffering from neurological, cardiovascular, and immunology diseases. With a strong foundation in cell biology and genetic engineering, we are advancing our novel cell+gene platform to create a new generation of authentic and engineered cell therapies.

Job Summary

We are seeking a highly experienced Vice President, Process Development to lead our process development function and oversee the development of phase-appropriate manufacturing processes for our cellular products. As a key member of our leadership team, you will be responsible for ensuring cross-functional alignment and technical outcomes, while influencing and providing technical guidance on process characterization, process robustness, and process control strategy.

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.
  • Strategize and 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.
  • Work closely with the SVP, Process & Analytical Development to establish and cultivate shared team values and continuously evolve the technical strategy in response to changing demands.
Requirements
  • Advanced degree in biological engineering, chemical engineering, biological sciences, or similar with 12+ relevant 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 includes pluripotent stem cells and differentiation thereof, bioprocess development for cell banks, Drug Substance, and/or Drug Product.
  • Proven ability to strategize, prepare, and execute on complex projects and programs in a fast-paced environment.
  • Excellent organizational and problem-solving skills, with demonstrated ability to extend these across a team and implement efficient operational processes.

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