Scientist I, CSI Development and Implementation Strategy
Toronto, Ontario
Technical Operations – GMP Manufacturing /
Full-time /
On-site
Who is BlueRock?
BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves.
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.
As part of BlueRock Therapeutics’ vision to change the future of medicine by enabling ground-breaking cell therapies, the candidate will be a technical contributor of a dynamic and innovative team developing formulations for cellular medicines.
The successful candidate will support the development of CSI (cell suspension for injection) formulation at BlueRock by identifying, designing, and testing formulations to optimize in-use stability, cell dose delivery, and cell persistence after transplantation. The ideal candidate will be a highly motivated individual who has demonstrated strong bench skills, excellent documentation skills, attention to detail and enjoys working in a highly cross-functional environment.
As a central development resource at the company, the CSI Development team works closely with other product development teams to understand requirements and develop cellular formulations for applications in therapeutic areas such as cardiology, neurology and immunology. Collaboration with a highly motivated, world-class team of scientists and engineers promises an exciting and engaging work environment for motivated, self-starting candidates.
Responsibilities:
- Support development of safe and efficacious injectable cellular medicines. Identify critical formulation parameters for optimal CSI in-use stability, cell dose delivery, and cell persistence after transplantation.
- Lead investigations for GMP deviations, including root cause analyasis and determination and implementation of CAPAs
- Act as technical contributor for formulation development and chemical, physical and biological characterisation of formulations. Troubleshoot technical issues that are encountered during formulation development, tech transfer, and clinical manufacturing.
- Plan, design, execute and analyse data for formulation development experimental studies.
- Independently identify, strategize, and ultimately solve complex technical problems with a broad scope within the function.
- Actively research scientific and technical topics and initiate efforts to evaluate or implement concepts into existing workflows/projects.
- Collaborate cross-functionally to solve scientific problems outside of function. Routinely serve as a resource for others, inside and outside of the function.
- Communicate effectively across functions, understand "big pictures" for projects while also beginning to understand the interdependences of seemingly diverse tasks.
- Skilled at carrying out scientific/technical presentations with confidence.
- Independently draft, edit, and finalize technical protocols and reports while interacting in a cross-functional environment.
- Mentor and motivate others in scientific and/or technical topics with the goal of enabling key activities to be completed appropriately and on-time.
- Lead technical project and manage the work of others within the functional area.
- This position requires hands-on laboratory work. Perform additional duties to support the safe and efficient operation of the laboratory, and other duties as assigned.
Minimum Requirements:
- Bachelor's degree in a scientific or engineering discipline and 10+ years of experience OR MS degree in a scientific or engineering discipline and 9+ years of experience OR PhD and 0-2 years of experience.
- Experience with formulation development, testing procedures, and equipment for physical and chemical characterization of the formulations is required. Experience with injectable drug product formulations is a plus.
- Experience leading deviation investigations in a GMP environment, including root cause analysis and CAPA implementation, utilizing Quality Management Systems.
- Broad knowledge of molecular and cell-based in vitro assays is required.
- A solid understanding of aseptic techniques in cell culture is required.
- Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint) and statistical analysis software (such as GraphPad, Minitab) is required.
- Self-motivated and with a proven ability to be highly productive and successful in a fast-paced work environment, with excellent attention to details and meticulous bench work. Collaborating with a cross-functional team, must be able to contribute to solving a wide range of complex problems in creative and practical ways.
- Excellent interpersonal, verbal and written communication skills.
Base Salary Range: $110,000 - $120,000
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BlueRock Therapeutics Company Culture Highlights
Winner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023
Winner of Comparably's Award for Best Company for Diversity 2022
Winner of Comparably's Award for Best Company for Women 2022
Winner of Comparably's Award for Best CEO 2022
BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.
Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably.
Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeutics
Follow us on Linkedin: https://www.linkedin.com/company/bluerocktx/
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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
