Analyst II, Analytical and Quality Control

BlueRock Therapeutics LP; Toronto; On-site; CAD 73,000 - 77,000; Full time

Job summary

BlueRock Therapeutics LP is seeking an Analyst II, A&QC to support QC testing requirements for cell-based therapeutics intended for human clinical trials. You will ensure GMP-compliant execution of test methods across materials, intermediates, final drug product and doses for the clinic.

You will perform training, documentation, and QC operations with a focus on accuracy, collaboration with Manufacturing, and external testing partners. Weekend work may be required.

Qualifications

• BSc in Life Sciences with minimum 3 years relevant experience in Cell Biology, Genetics, Biotechnology, Biochemistry or related field.
• MSc with minimum 1-year relevant experience preferred.
• Strong preference for experience in Quality Control and Good Documentation Practices in a cGMP or equivalent environment.
• Experience with nucleic acid extraction, liquid handling, qPCR, ddPCR, pluripotent stem cell culture, sequencing.

Responsibilities

• Effectively train on and execute assigned QC testing procedures and perform new assignments with general instructions and minimal supervision.
• Support documentation for cGMP production, in-process testing, stability and release testing of cell therapy products
• Support QC functions for laboratory operations, including equipment maintenance, review and tracking of samples, testing results, materials inventory, and reagent preparation.
• Support testing execution as required for transfer of QC test methods, characterization assays and/or qualification of methods.
• Review sampling plans and support COA issuance for batch disposition
• Author or review GMP documentation for accuracy and compliance (e.g. methods, protocols, executed records) with thorough understanding of technical area of specialization.
• Report and initiate quality events and leverage technical knowledge to define solutions to moderately complex problems.
• Liaise with CROs for sample submissions and external testing results reporting.
• Other duties as required.

Skills

Life Sciences

Analytical skills

Attention to detail

Independent worker

Education

BSc in Life Sciences

MSc preferred

Tools

qPCR

ddPCR

Pluripotent Stem Cell culture

Sequencing

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, 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:

Analyst II, A&QC will support the QC Testing requirements of cell-based therapeutics destined for human clinical trials, from starting materials to final differentiated cell therapy. The AQC Analyst II will ensure QC Test methods are executed in a GMP compliant manner for samples generated by Manufacturing, including Raw Materials, Intermediates, Final Drug Product and through to Doses prepared for the clinic.

Responsibilities:

• Effectively train on and execute assigned QC testing procedures and perform new assignments with general instructions and minimal supervision.
• Support documentation for cGMP production, in-process testing, stability and release testing of cell therapy products
• Support QC functions for laboratory operations, including equipment maintenance, review and tracking of samples, testing results, materials inventory, and reagent preparation.
• Support testing execution as required for transfer of QC test methods, characterization assays and/or qualification of methods.
• Review sampling plans and support COA issuance for batch disposition
• Author or review GMP documentation for accuracy and compliance (e.g. methods, protocols, executed records) with thorough understanding of technical area of specialization.
• Report and initiate quality events and leverage technical knowledge to define solutions to moderately complex problems.
• Liaise with CROs for sample submissions and external testing results reporting.
• Other duties as required.

Minimum Requirements:

• BSc in Life Sciences with minimum 3 years relevant experience in Cell Biology, Genetics, Biotechnology, Biochemistry or related field.
• MSc with minimum 1-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 one or more of the following techniques is required: nucleic acid extraction, liquid handlers, qPCR, ddPCR, Pluripotent Stem cell culture, sequencing
• 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.
• Weekend work on an as needed basis may be 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 $ 73,000.00 - $ 77,310.00 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.

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.