Vice President, Regulatory Affairs

2 weeks ago

Toronto ON, Canada BlueRock Therapeutics Full time

BlueRock Therapeutics is seeking a Vice President, Process Development based out of our Toronto, ON Canada facility, reporting to the Senior Vice President of Process & Analytical Development. This global leadership role will oversee the process development function with a presence in multiple locations. As the department works closely with Research, Non-clinical, Analytical, Quality, and GMP Operational teams, this role will ensure cross-functional alignment while owning technical outcomes. This leader will lead a sizeable team of scientists and engineers to develop phase-appropriate manufacturing processes inclusive of in-process controls and novel platforms, that meet both quality compliance standards and regulatory requirements. In addition, this role will influence and provide technical guidance around topics including but not restricted to: process characterization, process robustness, process control strategy, organizational structure, and root cause investigations. This is an outstanding opportunity for a talented and self-motivated leader to contribute to bringing cutting-edge cellular therapies to patients while building a sustainable organization.
Lead the process development team to develop, optimize, scale-up and troubleshoot the manufacturing processes for authentic and engineered cellular products.
Thought leader in the Process & Analytical Development organization and the Tech Ops extended leadership team, working in partnership with other leaders to develop and administer the operating plans and budgets contributing to the achievement of corporate goals.
Lead the identification, evaluation, and implementation of new technologies.
Provide strong 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.
Advanced (PhD) 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.
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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