Scientist II, MSAT

Responsibilities:

• 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 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 subject‑matter expert during GMP operations, providing real‑time troubleshooting and root‑cause 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 lifecycle‑management 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