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? Ourfoundational scienceharnesses 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 ensures that our iPSCderived 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 endtoend DS/DP operationsowning process understanding, defining manufacturing readiness, and driving technology transfer to internal and external sites. The roles is also accountable to provide 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. Responsibilities: Lead tech transfer activities between internal R&D, external CDMOs, and internal manufacturing teams, consistent with MSAT''s role as a central techtransfer function. Lead cross-functional workstreams 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 United States (i.e. FDA) and other global health authorities Define and communicate critical process parameters (CPPs), critical quality attributes (CQAs), and operational ranges. Partner with process development to define these as phase appropriate. Prepare technical reports, risk assessments, process maps, and scientific summaries. Conduct facility fit, equipment readiness, and gap assessments. Ensure accurate, compliant, and timely documentation of manufacturing support activities. Serve as a technical subjectmatter expert during GMP operations, providing realtime troubleshooting and rootcause analyses. Lead or perform investigations including impact assessments, root cause analysis, and corrective and preventative action implementation. Monitor process performance, identify trends, and drive continuous improvements aligned with lifecyclemanagement expectations for MSAT cell therapy programs. Lead matrix teams to facilitate data analysis of manufacturing data including raw materials, in-process measurements, and final release assay data including trending and reporting to management. Be a sought-after partner on deviations, CAPAs, change controls, and regulatory responses. Drive continuous improvement efforts from concept to implementation in the GMP environment. Implement technology into GMP environments. Prepare and present scientific data and technical information internally and externally as required. Contribute to building a culture that embraces scientific excellence, integrity, urgency, courage and community and provide scientific and technical supervision to junior staff, peer functions, and external organizations. Minimum Requirements: Degree in chemical engineering, bioprocessing science, biological sciences or similar with 5+ (PhD), 9+ (MSc), or 11+ (BS) years of biotechnology industry experience in a contract research organization, biotechnology or pharmaceutical company, or similar industry environment. Strong preference for experience in the cell therapy modality, pluripotent stem cells, manufacturing process development, tech transfer, and cGMP manufacturing. Significant hands-on experience in developing, optimizing, implementing, and qualifying cell culture processes according to industry best practices is required A solid understanding of aseptic techniques and technologies in cell culture is required. Proven experience supporting GMP manufacturing operations. Experience implementing new equipment, raw materials or procedures into a GMP environment. Demonstrated supervisory and mentoring skills in leading scientific and technical staff. Experience with Good Documentation Practices and working in a cGMP or equivalent environment is preferred. Excellent organizational and problem-solving skills, with demonstrated ability to lead cross-functional teams. Experience leading the activities of external partner organizations required. Excellent written and oral communication skills, with strong organizational skills and keen attention to detail. Working knowledge of statistics and data trending using statistical programs and software is preferred. Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint). Frequent travel expected and required (~15-35%) especially across BlueRock sites and to external partner organizations and facilities. Target Base Salary: $115,000 - $136,400 #LI-AL1 BlueRock Therapeutics Company Culture Highlights Winner of Boston Business Journal''s Best Places to Work (Mid-size Company) 2023 Winner of Comparably''s Award for Best Company for Diversity 2022 Winner of Comparably''s Award for Best Company for Women 2022 Winner of Comparably''s Award for Best CEO 2022 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.
Job Title
Scientist II