Scientist II, MSAT

Who is Blue Rock?

Blue Rock 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. Blue Rock 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.

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.

Based in Toronto, Ontario or Cambridge, MA, USA, the Scientist II - MSAT ensures that our iPSC‑derived cell therapy processes run reliably, compliantly, and efficiently as programs progress from development to GMP manufacturing. Operating at the intersection of Process Development, Manufacturing, Quality, and Supply Chain, you will serve as the technical steward for end‑to‑end DS/DP operations—owning process understanding, defining manufacturing readiness, and driving technology transfer to internal and external sites.

The role also accounts for providing daily manufacturing operations support (own technical investigations) and drive continuous improvement (both technical & business process related) including the leading of new technology implementation into GMP environments. The individual is also accountable for building and maintaining process monitoring frameworks to enable forward thinking data driven decision making.

The Scientist II must excel in fast-paced 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.

• Lead tech transfer activities between internal R&D, external CDMOs, and internal manufacturing teams, consistent with MSAT’s role as a central tech‑transfer function.
• Lead cross‑functional work streams spanning diverse internal and external stakeholders including process development, analytical development, manufacturing, quality control, quality assurance, supply chain, CMC, clinical development, and clinical operations.
• Fulfill project management activities including establishing experimental or manufacturing strategy, planning technical operations both internally and externally, drafting and maintaining timelines in support of therapeutic program teams, identifying/tracking/mitigating risks to process performance or product quality, authoring contracts with external partners, and reporting status updates or outcomes to functional and program management stakeholders.
• Author technical documents in support of technology transfer including but not limited to: process descriptions, process parameter specifications, process control strategy, user requirement specifications, functional requirement specifications, software design specifications, tech transfer plans, standard operating procedures, master batch records, protocols, and summary reports.
• Author technical source documents intended for a Quality Management System (QMS) and regulatory source documents intended for submission to…