Senior Analyst, Analytical and Quality Control

BlueRock Therapeutics Canada ULC; Toronto; On-site; CAD 118,000 - 125,000; Full time

Job summary

BlueRock Therapeutics Canada ULC seeks a Senior Analyst, Analytical and Quality Control to support GMP testing for cell therapies intended for human clinical trials. The role ensures QC methods are GMP compliant and supports raw materials, intermediates, final drug products, and doses prepared for the clinic.

The position involves SOP writing/review, coordinating GMP documentation, and collaboration with QA, Manufacturing, and CROs.

Qualifications

• BSc in Life Sciences with relevant experience.
• MSc preferred; 3+ years in related field.
• Experience in Quality Control and cGMP environments.
• Experience in flow cytometry-based assays required.

Responsibilities

• Perform and/or support QC testing for cell therapy samples.
• Support materials, in-process tests, release testing.
• Liaise with CROs for external testing and data reporting.
• Write, review, and maintain GMP SOPs and QA documents.
• Support QA/QC for laboratory and cleanroom operations.
• Ensure documentation compliance and data integrity.

Skills

Flow cytometry

Good Documentation Practices

Quality Control

Cell biology

Education

BSc in Life Sciences

MSc in Life Sciences

Tools

qPCR/ddPCR

Pluripotent Stem Cell culture

Fluorescence microscopy

High throughput imaging

Next generation sequencing

ELISA

HPLC

Job description

BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company pioneering a new generation of cellular medicines. Utilizing our proprietary CELL+GENE™ platform, we direct cellular differentiation and genetically engineer cells to create transformative therapies for patients suffering from neurological and ophthalmological diseases. Founded in 2016, BlueRock is at the forefront of the convergence of cell biology and genetic engineering. Our mission is to harness pluripotent stem cell technology and gene editing to deliver authentic, functional cell therapies that address the root causes of disease and offer hope to millions of patients worldwide.

What Are We Doing? Our foundational science enables the generation and directed differentiation of universal pluripotent stem cells into authentic, functional cells for allogeneic cellular therapies. We are passionate about realizing the promise of cell and gene therapy, shaping the future of regenerative medicine, and delivering new therapies to patients with limited or no treatment options.

Who is BlueRock?

BlueRock Therapeutics LP is a clinical stage cell therapy company 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.

Description of Position:

The Senior Analyst, Analytical and Quality Control will support the GMP testing requirements of cell-based therapeutics destined for human clinical trials, from starting materials to final differentiated cell therapy. The Senior Analyst will ensure that QC Test methods are executed in a GMP compliant manner for samples generated by Manufacturing, as well as raw Materials, intermediates, final drug product and through to doses prepared for the clinic. Additionally, the analyst will execute characterization and non-GMP tests to support cell therapies process characterization. Additional duties will include writing and reviewing Standard Operating Procedures (SOPs) related to QC functions, and coordinating the revision, review, and approval of SOPs and other GMP documents that are necessary for ensuring testing is compliant with applicable U.S., Canadian and global standards.

Responsibilities:

• Perform and/or support QC testing activities for samples generated for release testing and compliance of cell therapies destined for human clinical trials, as well as materials used in their production, with a focus on flow cytometry & cell-based assays.
• Support process implementation for sample receipt, and in-process and release testing of raw materials, cell lines, process intermediates, drug products and other materials.
• Support cell based and molecular testing, as needed.
• Liaise with CROs for sample submissions and external testing results reporting.
• Support testing execution as required for transfer of QC test methods, characterization assays and/or qualification of methods.
• Perform instrument maintenance, antibody titrations, liaise with external instrument service representatives as needed.
• Write, review and drive approval of SOPs related to quality control testing including test methods, equipment operation and maintenance procedures.
• Support Quality Assurance (QA) documentation functions for cGMP production, in-process testing and release testing of cell therapies.
• Support QA and QC functions for laboratory operations, including equipment maintenance, review and tracking of samples, testing results, materials inventory and reagent preparation.
• Support QA and QC functions for cleanroom operations, including review and tracking of Environmental Monitoring data and cleanroom maintenance practices.
• Other duties as required.

Minimum Requirements:

• BSc in Life Sciences with minimum 5 years relevant experience in Cell Biology, Genetics, Biotechnology, Biochemistry or related field.
• MSc with minimum 3-year relevant experience preferred.
• Strong preference for experience in Quality Control and experience with Good Documentation Practices and working in a cGMP or equivalent environment.
• Experience in flow cytometry based assays is required.
• One or more of the following techniques is preferred: qPCR/ddPCR, Pluripotent Stem cell culture, Fluorescence microscopy, High throughput imaging, Next generation sequencing, ELISA, HPLC.
• Experience in the following areas is highly desirable: cell therapy, pluripotent stem cells, gene editing, biotech.
• Excellent written and oral communication skills, with keen attention to detail and highly organized.
• Demonstrated flexibility in adjusting to changing priorities and schedules.
• Ability to work independently in a fast-paced, collaborative environment with a team-oriented focus.
• Flexibility to work off-hours, and weekends on an as-needed basis is required.

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.

The estimated compensation range for this position is $ 83,000.00 - $ 88,020.00 per year.

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.

BlueRock Therapeutics is a clinical stage cell therapy company focused on creating cellular medicines to treat devastating diseases. We are 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, one for the treatment of Parkinson’s disease and one 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, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, BlueRock became a wholly owned, independently operated subsidiary of Bayer AG. 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.