Senior Director, MSAT

BlueRock Therapeutics LP; Toronto; On-site; CAD 319,000 - 338,000; Full time

Job summary

BlueRock Therapeutics, based in Toronto, seeks a Senior Director of MSAT to lead the transfer of pipeline assets into a new GMP facility and bridge Process Development with manufacturing. The role emphasizes automation, data integrity, and scalable operations to support clinical supply.

The candidate will build a high-performing MSAT team, lead internal and external transfers, and ensure regulatory compliance while delivering manufacturing excellence for the expanding pipeline.

Qualifications

• Advanced degree and 15+ years in biotech MSAT leadership or related roles.
• Experience leading technology transfers and startup of new GMP operations.
• Strong understanding of regulatory expectations and GMP compliance.

Responsibilities

• Establish the MSAT operating model across product lifecycle and ensure successful technology transfer.
• Mentor, lead and grow a high-impact MSAT organization across disciplines.
• Enable growth through standardized processes across internal and external manufacturing networks.
• Oversee technology transfers, process monitoring, and CAPA-driven improvements.
• Drive operational readiness for the new GMP facility and support NPI processes.
• Develop automation and digital solutions to improve productivity and data integrity.

Skills

Biotech leadership

MSAT expertise

Technology transfer

GMP manufacturing

Regulatory knowledge

Data-driven decisions

Education

Advanced degree in Chemical/Biomedical/Biotech/Life Sciences

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 two therapeutic areas: neurology 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.

Who is BlueRock?

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

Based in Toronto, Ontario the Senior Director of MSAT will have a unique opportunity to: Build a high performing organization that bridges Process Development with GMP manufacturing & supports existing operations, both internal and external. Identify, evaluate, and deploy automation solutions in both non-GMP and GMP environments that improve process robustness and operational efficiency. Drive the operational readiness & technical startup of our new, state-of-the-art cell therapy manufacturing facility in the Greater Toronto Area. The role is accountable for advancing BlueRock's pipeline by leading efficient internal and external technology transfers, providing strategic manufacturing support, and driving complex process investigations. This individual will establish and maintain robust process monitoring frameworks that enable proactive, data-driven decision making, enhance process understanding, and accelerate continuous improvement across the manufacturing network. You will lead the identification, evaluation, and deployment of automation and digital technologies across manufacturing and R&D operations. Accountable for developing automation value propositions, building business cases, and implementing innovative solutions that improve process robustness, operational efficiency, data integrity, scalability, and cost of goods while ensuring GMP compliance and inspection readiness. For our new site, located in the Greater Toronto Area, you will hold ultimate accountability for the operational readiness and technical startup in support of BlueRock’s pipeline. You are directly responsible for executing the successful technology transfers of BlueRock assets into the new facility. Your goal is establishing a high-performing operation that secures a reliable clinical supply of these advanced therapies at our new location. The Senior Director of MSAT must excel in fast-paced & blank slate environment, work well cross functionally and be a well-structured worker. A successful candidate will execute on tasks on hand and further develop their SME knowledge of the process independently.

Responsibilities

MSAT Leadership

Establish the MSAT operating model and ways of working that drive technical excellence across the product lifecycle, ensuring successful technology transfer, manufacturing readiness, & process performance. Build, mentor, and lead a high-impact MSAT organization across disciplines.

Enable growth across the internal & external manufacturing network

Enable growth across the internal & external manufacturing network through standardized ways of working, effective governance, and scalable technical processes.

Technology Transfers, Process Monitoring & Continuous Improvement

Partner with Process Development to ensure right-first-time technology transfer into internal & external manufacturing sites, ensuring operationalization of process knowledge, documentation readiness, and training for GMP execution. Partner with Manufacturing to develop a lean, repeatable and risk tolerant internal NPI process. Own and maintain the integrity of process monitoring databases utilizing statistical tools to monitor process variability, analyze trends, detect shifts, quantify variation, identify signals requiring investigation, and drive data-based insights and decisions. Lead investigations and technical risk assessments for major deviations, OOS/OOT, and atypical events—ensuring timely root cause, effective CAPAs, and sustained improvements. Drive continuous improvement through process optimization, standardization, and lean problem solving, while maintaining compliance.

Raw Materials

Provide MSAT leadership for material qualification, supplier changes, and risk management (critical raw materials, reagents, single-use systems). Partner with Supply Chain and Quality to ensure technical oversight for supplier network robustness, including dual sourcing strategies where appropriate.

Drive Productivity in GMP & Non-GMP Environments

Deploy both technical and business process automation solutions that increase productivity while maintaining CMC timelines. Partner with PD to develop and maintain a technology roadmap, maintain awareness of industry technology trends and deploy these as required.

Drive Operational Readiness at our New GMP Facility

Serve as the MSAT lead in facility startup activities, partnering with Engineering, Manufacturing, Quality, and Project teams to ensure a seamless transition from project delivery to routine operations and sustained manufacturing performance. Define the manufacturing technology transfer framework and oversee the transfer of products and processes into the new facility, ensuring successful execution, knowledge transfer, and process performance. Align stakeholders on business plans for transfers of pipeline assets.

Minimum Requirements

• Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Life Sciences, or a related field.
• 15+ years of experience.
• Extensive leadership experience within biotechnology manufacturing organizations, with progressive responsibility across MSAT, process engineering, technical operations, or manufacturing support functions.
• Previous experience starting up a new GMP operation.
• Previous experience designing and implementing new technologies.
• Strong background in cell therapy and advanced biologics manufacturing, including experience supporting products through development, clinical manufacturing, and commercialization.
• Demonstrated success managing technology transfers and building effective partnerships across internal manufacturing sites, CMOs, and external collaborators.
• Proven ability to lead complex technical organizations, drive operational excellence, and deliver results in a fast-paced and evolving environment.
• Strong knowledge of regulatory frameworks.

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 $ 230,000.00 - $ 243,630.00 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.