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BlueRock Therapeutics Associate Director/Director, Process Development in New York, New York

Who is BlueRock?

BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.

The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology.

What Are We Doing?

Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.

We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.

We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.

Description of this Position

BlueRock Therapeutics is seeking a Director/Sr Dir, Process Development at our Toronto Location, reporting to the Vice President of Process Development. As a central development resource at the company, the Process Development team works closely with research, non-clinical, analytical, manufacturing, and quality teams. As a leader within this Function with a focus on late-stage development for authentic and engineered cellular products, this position will lead a team of Scientists to develop commercial manufacture processes, perform process characterization, and provide process control strategy for process performance qualification (PPQ), regulatory filing and response to questions from regulatory agencies. This is an outstanding opportunity for a talented and self-motivated leader to contribute to bringing cutting-edge cellular therapies to patients while gaining valuable career experience in Process Development.

Responsibilities:

  • Lead process development team to develop, optimize, scale up and tech transfer the manufacturing process for authentic and engineered cellular products.

  • Strategic partner on the Process Development leadership and Tech Ops extended leadership team, working in partnership with management to develop and administer the operating plans and budgets contributing to the achievement of programmatic and institutional goals.

  • Lead the development and implementation of new technologies; establish and improve manufacturing process platforms for authentic and engineered cellular products.

  • Provide strong oversight, leadership, career development and subject matter expertise to a diverse team of process development scientists, and associates.

  • 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 CMC sections of IND/INDa/BLA and respond to regulatory questions

  • Present scientific data to colleagues in group meetings, prepare and present internal and external presentations (presentations, posters, publications), author and submit articles to peer-reviewed journals as required

  • Work closely with the VP, Process Development to establish and cultivate shared team values and continuously evolve the technical strategy in response to changing demands

Requirements

  • Advanced (PhD or MS) degree in biological engineering, chemical engineering, biological sciences, or similar with 10 - 12+ (PHD) or 15+ (MS) relevant years’ experience in industry and/or academia

  • Proven cross functional senior leadership capabilities with seasoned experience in people management, sub-functional oversight and development

  • Strong communication skills, able to manage effectively multiple level communications up to top management and down to project team members; able to manage cross-sites and cross-functional communications

  • Hands-on experience in mammalian cell culture, ideally includes pluripotent stem cells and differentiation thereof, bioprocess development for the manufacture of cell & gen biological therapeutics.

  • Proven ability to structure, plan, 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.

  • Experience in supervising and guiding employees and working collaboratively in a matrix environment is preferred.

Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

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