Product Quality Scientist

2 days ago

Toronto, Canada BlueRock Therapeutics Full time

**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.

As part of BlueRock's vision to change the future of medicine by enabling ground-breaking cell therapies, we’re looking for a Product Quality Scientist, specialized in cellular biology, to support a dynamic and progressive Analytical Sciences Technology and Quality Control team (AST&QC). The position requires a data driven scientist with an analytical mindset who has great communication skills and will thrive in a cross-functional team environment. Familiarity with work under GLP or GMP regulations is a plus.
- Reporting to the Product Quality Senior Scientist of AST&QC, the Scientist will be a key analytical contributor of the product quality team establishing the analytical strategy, life-cycle improvements, and control strategies to progress clinical programs to commercial readiness, from starting pluripotent stem cell materials to final differentiated cell therapy.

**Responsibilities**:

- Champion product quality for assigned program, supporting a proactive team approach to evaluating the quality of cell seeds, banks, intermediates, drug substance and drug products for cellular therapeutics and all related inputs.
- Work with project teams to establish alignment on analytical strategies throughout the lifecycle of the product.
- Collate and analyze data throughout the product lifecycle to support process comparability, and the establishment of specifications for CQA through release and stability testing.
- Liaise with different departments within TechOps (manufacturing, process development, analytical development, formulations) and across CMC to support assessments of QTPPs, CQAs and analytical methods to evaluate CQAs and monitor process.
- Implement Phase-appropriate Risk Assessments to support and enable Process Characterization strategy.
- Support investigations related to product quality and in line with overarching analytical strategy.
- Author and review overarching technical protocols and reports and analytical sections of regulatory documents for submission to Health Authorities/ Regulatory agencies,
- Track progress of activities supporting the analytical strategy, and their impact to understanding of product quality.
- Ensure that product quality aligns with regulatory requirements in all regions relevant to the company, in compliance with the Quality Management System.
- Prepare and present technical information relating to product quality internally and externally.

**Minimum Requirements**:

- Master’s degree in Biological Sciences with Minimum of 9 years of relevant experience, PhD with product quality experience preferred.
- Good understanding of Cell Biology and attributes of cellular therapeutic, as well as an in-depth knowledge of the analytical methods being used to define product quality.
- Good understanding of Quality by Design principles, regulatory guidelines and analytical life cycle management are an asset.
- Strong preference for experience in the Biotechnology setting, particularly cell therapy, pluripotent stem cells, gene editing.
- Experience with Good Documentation Practices and working in a cGMP or equivalent environment is preferred.
- Experience in qualification, validation, transfer, and life cycle management of analytical methods is desirable but not required.
- Experience with writing technical reports, and regulatory documents presenting data clear

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