Job Description

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\xe2\x80\x99 lives.


BlueRock Therapeutics is looking for a scientist who is self-motivated, innovative, and results-oriented to participate in the development of cryopreservation process for various iPSC-derived cell and gene therapy products. The candidate will primarily work on evaluating cryopreservation formulations and process protocols for both intermediate cells and final drug product using an array of high throughput and sensitive analytical techniques. The candidate will apply fundamental cryobiology principles to conduct cryoformulation screening, while applying appropriate techniques to characterization cell quality and stability attributes. The candidate will be part of a cross-functional matrix and work closely with PD and other internal CMC partners including R&D, AD, QC and QA.


This role is based in Toronto, ON (M5G 1L7)

Responsibilities:

• • Develop and perform process analytics to monitor the process performance, improve process understanding and characterize iPSCs and differentiated cellular products.
  • Drive scientific understanding of the bioprocesses and the cellular products. Evaluate and implant new technologies to the state-of-the-art cellular therapy process.
  • Train and supervise junior staff members in supporting CMC/IND related activities, including but not limited to protocol driven studies to support process change, premanufacture pilot production and method qualification.
  • Perform technology transfer of cell manufacturing processes to cGMP-compliant manufacturing facilities within the company or to CMOs.
  • Analyze and document experimental data in electronic laboratory notebooks in a timely and accurate manner in accordance with the company quality management system.
  • Prepare experimental proposals, standard operating procedures, batch records and other process and cGMP documentation.
  • Prepare and present hypotheses, on-going progress reports, technical reports and future plans
  • Co-ordinate and interact with other functions to ensure a thorough understanding of the requirements for the manufacture of iPSCs and derivatives in a cGMP compliant manner
  • Assist in preparation of CMC sections of regulatory applications
  • Present scientific data to colleagues at internal meetings, prepare and present internal and external presentations

Minimum Requirements:

• • Advanced (MS or PhD) degree in Biomedical Engineering, Chemical Engineering, Biological Sciences, or similar
  • MSc. 6-9+/ PhD 0-2 years of experience, preferably in an industry setting
  • Extensive mammalian cell culture and cell characterization experience is essential, ideally with PSCs and PSC-derived cells
  • Hands on expertise in developing cryopreservation processes and broad knowledge in cryobiology are required
  • Familiarity with cell characterization methods and technologies (e.g., flow cytometry, qPCR, microscopy) is essential
  • Demonstrated ability to plan experiments and independently execute complex tasks
  • Hands on experience with bioreactors and cell processing technologies is desirable
  • Hands on experience with automation platforms (liquid handlers) and for cell culture and assay development is a bonus
  • Practical knowledge of experimental design and statistical analysis of data are desirable
  • A fundamental experience of coding (e.g. Python or Matlab) for data analysis and visualization is a big plus
  • Strong English written and verbal communications skills
  • Proficiency in scientific writing

#LI-MM1


BlueRock Therapeutics Company Culture Highlights
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


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.