Senior Director, Quality Control and Analytical Sciences &Technology (QC&AST)

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.
BlueRock has a fantastic opportunity for an experienced, dynamic analytical leader to join our growing team! The Senior Director, Quality Control and Analytical Sciences &Technology (QC&AST) is responsible for leading the analytical strategies in QC Testing and Operations groups in Toronto, Canada and facilitating the expansion of the QC&AST capability to other internal BlueRock sites. This role, reporting the VP of QC&AST, will be responsible for leading all internal and external preclinical and clinical testing as the leader of subject method experts. Additionally, they will manage vendor relations for the external testing sites and establish & manage all laboratory operations to ensure the process is efficient, on time, on budget, and executed with highest quality. This role will lead technical analytical staff to create a center of excellence for testing of our products. This will mean establishing an exemplary asset and reagent management program, developing Quality systems and tools to support and follow on with critical technical Out Of Specifications (OOS) /Trend (OOT) Investigations. This role will lead a large QC organization to comply and implement Health Authority requirements, support inspections, and participate in writing, reviewing and approving analytical sections of the technical reports and regulatory documents.Responsibilities:

Provide leadership and expert knowledge on the development, assessment, and continued enhancement of lab operations and GMP testing cell+gene therapy products consistent with BlueRock’s operational plans

Manage key initiatives for improvement QC method performance, trend and remediation.

Provide leadership to the QC Testing and Operations functions, including hiring, mentoring, and developing staff members to ensure projects are adequately staffed

Interface with Research and Development, Assay Development, Quality Assurance, Process Development, CMC and Project Management, and Technical Operations Teams to advance BlueRock Portfolio to complete milestones within timelines.

Manage collaborative relationships with key internal and external stakeholders including but not limited to parent Company (Bayer)

Ensure successful execution and transfer of methods and know-how to analytical teams externally testing labs and technologies to support Process Development and MSAT/Tech teams

Direct comprehensive validation activities including planning and execution of validation activities for equipment, sample handling, QC processes and vendor relations.

Manage and oversee the identification, procurement, installation, and maintenance of all critical laboratory equipment

Ensure QC support for internal teams on inspections, audits, preparation of documents for IND filings for characterization, release and stability testing  

Identify and implement optimization of the existing tools, systems and governance to enhance QC performance and metrics.

Contribute to functional budget planning and approve proposed budgets for supporting teams and sub-functions

Other duties as assigned

Minimum Requirements:

PhD or Master’s Degree in Chemistry, Biology, Bioengineering or related field with 15+ years of relevant industry experience

10+ years of managing GMP functions, vendor relations and technical professionals

Expertise in phase appropriate GMP testing, and Lab Operations of cell therapies or biologics

Expertise in qualification, validation, transfer and life cycle management of analytical methods is desirable

Experience in Health Authority Inspections, related observations and implementation of CAPAs

Proven record of highly developed communications, and ability to navigate highly collaborative workstreams with internal and external stakeholders

Self-Directed work etiquette: do-what-it-takes attitude in a goal-oriented environment is required

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BlueRock Therapeutics Company Culture HighlightsWinner of Comparably's Award for Best Company for Diversity 2022Winner of Comparably's Award for Best Company for Women 2022Winner of Comparably's Award for Best CEO 2022BlueRock 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: https://www.comparably.com/companies/bluerock-therapeutics
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.