Quality Control Scientist (Flow Cytometry)
BlueRock Therapeutics, Canada
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’ lives.
Description of Position:
As part of BlueRock's vision to change the future of medicine by enabling ground-breaking cell therapies, we’re looking for a QC Scientist, specialized in Flow Cytometry to support a dynamic and progressive analytical team.
Reporting to the Director of Quality Control, the Scientist (Flow Cytometry) will be a key technical contributor of an analytical team establishing the QC testing methodology of cell-based therapeutics destined for human clinical trials, from starting stem cell materials to final differentiated cell therapy. The successful candidate will drive the analytical lifecycle of methods in a GMP-compliant environment, including test transfers of methods into QC, qualification or phase-appropriate validation, establishment of reference standards, troubleshooting and training.
This is an exciting opportunity for a highly motivated individual to lead from the bench in technically complex methods, solving a wide range of challenging problems in creative and practical ways with a collaborative approach across QC and Analytical groups.
Responsibilities
- Champion assessing and implementing new technologies, processes and methods critical to safety and quality of cell seeds, banks, intermediates, drug substance and drug products for cellular therapeutics and other materials.
- Liaise with project teams to establish and perform test transfer of scientifically sound QC test methods to be used for the release and/or characterization of cell therapies.
- Establish and execute studies to qualify and/or validate QC test methods in a clinical phase-appropriate manner. Identify and determine appropriate ranges of (critical) assay parameters to ensure robust, repeatable, and accurate results.
- Work with project teams to establish reference standard materials for PSC banks and differentiated cell products to support cell therapy programs.
- Act as Subject Matter Expert to support training of QC specialists in test methods and analytical instruments.
- Lead laboratory investigations to evaluate out-of-specification and atypical results within QC methods, including troubleshooting of invalids and monitoring method performance.
- Ensure that experiments, analytical methods and data meet the requirements for the intended use of assays, which includes lot release, comparability and/or characterization.
- Collect and analyze data from various assays, track and trend data and supporting the establishment of specifications for critical quality attributes.
- Document experimental data in a timely and accurate manner following good documentation practices and in accordance with the company quality management system.
- Author and review SOPs, study protocols, reports and other scientific and quality documents.
- Ensure that assays meet regulatory requirements in all regions relevant to the company, in compliance with the Quality Management System.
- Prepare and present scientific data to colleagues in group meetings, prepare and present internal and external presentations (presentations, posters, publications) as required.
- Perform additional duties to support the safe and efficient operation of th