Analyst II

BlueRock Therapeutics

Toronto, Ontario, Canada

Toronto, Ontario, Canada

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About

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
Reporting within the Analytical and Quality Control team (AQC), Analyst II position will support the QC Testing requirements of cell-based therapeutics destined for human clinical trials, from starting materials to final differentiated cell therapy. Analyst II is responsible for performing QC test methods in compliance with GMP standards on samples received from the GMP Manufacturing team. This includes testing Raw Materials, Intermediates, Final Drug Product, and doses prepared for clinical use. Duties will include supporting method readiness, test execution, review, COA issuance for internal and external clinical hubs for patient dosing, ensuring that testing is compliant with applicable U.S., Canadian and global standards. This position requires frequent work outside standard business hours and occasional weekend work Responsibilities:

Perform and/or support QC testing activities for samples generated for release testing, with a focus on Cell Suspension for Injection (CSI) for the bemdaneprocel program for human clinical trials, as well as materials used in production of CSI.

Drive the documentation workflow to issue Certificate of Analysis for testing performed at internal and external hubs in compliance with established SOPs and regulatory standards

Liaise with CROs and/or external collaborators to receive and complete reporting of external testing results

Escalate out-of-specification results by following communication plans and liaise with management and related teams to resolve deviations and/or out-of specification results.

Additionally, support process implementation for sample receipt, and in-process and release testing of raw materials, cell banks, process intermediates, drug products and other materials for other clinical programs, where needed

Perform method verification for compendial methods, and procedural training of additional members of the QC testing team

Support authoring and review, drive approval of SOPs related to quality control testing including test methods, and equipment operation and maintenance procedures, where applicable.

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.

This position requires occasional weekend and some differential shift work hours.

Other duties as required.

Minimum Requirements:

BSc in Life Sciences with 2+ years of work experience or Masters with 0+ years of work experience with relevant background in Cell Biology, Genetics, Biotechnology, Biochemistry, compendia methods or related field.

Working knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) is strongly preferred.

Knowledge or Experience in one or more of the following methods preferred: Endotoxin USP, Sterility USP , pH USP , Osmolality USP , cell counts for cell therapy etc.

Knowledge or hands-on experience in the following areas is highly desirable: cell therapy, pluripotent stem cells

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 under moderate supervision in a fast-paced, collaborative environment with a team-oriented focus.

Target Base Salary - $72, ,500

#LI-AL
BlueRock Therapeutics Company Culture Highlights Winner of Boston Business Journal's Best Places to Work (Mid-size Company Winner of Comparably's Award for Best Company for Diversity Winner of Comparably's Award for Best Company for Women Winner of Comparably's Award for Best CEO 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: Follow us on Linkedin:
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.

Toronto, Ontario, Canada

Languages

English

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