QC Manager

About Us: BrainXell is a growing biotechnology company that is dedicated to the development of innovative therapies for neurological disorders. While BrainXell focuses on providing cutting-edge technologies for neuroscience research, BrainXell Therapeutics leverages these advancements to translate scientific discoveries into tangible treatments for patients. Position Summary: We are seeking a proactive and detail-driven Quality Control (QC) Manager to oversee day-to-day QC operations and ensure consistent execution of GMP-compliant testing for our iPSC-derived neuronal cell therapy programs. Reporting to the Associate Director of Quality, the QC Manager plays a key role in coordinating resources, supervising lab personnel, implementing QC systems, and supporting regulatory readiness. This role is ideal for someone with strong technical acumen and people management skills who thrives in a fast-paced, early-stage biotech environment and is eager to grow with the organization. Key Responsibilities: Operational Leadership & Team Oversight In collaboration with the Executive team and critical business partners, assist in establishing QC operations for clinical stage readiness Manage daily QC operations to ensure timely and accurate execution of release, stability, and in-process testing. Maintain a GMP compliant lab by overseeing equipment calibration, lab supply inventory, and general infrastructure needs. Ensure compliance with SOPs, safety policies, and GxP best practices across all QC activities. Supervise QC analysts and scientists, including performance management, scheduling, training, and mentoring. Manage sample submission and data receipt from third-party analytics vendors. Collaborate with manufacturing to maintain chain of custody between manufacturing production and QC sample preparation for onsite and third-party analytics. Method Support & Execution Support the execution and routine use of cell-appropriate analytical methods, including flow cytometry, ddPCR, ELISA, and cell-based potency assays. Coordinate with Analytical Development scientists to transfer and qualify new methods into the QC lab. Troubleshoot assay issues and work with technical leads to improve method robustness and reproducibility. Documentation & Quality Systems Review and approve QC records, test results, deviations, and OOS investigations. Contribute to the drafting and maintenance of SOPs, test methods, protocols, and CoAs. Support CAPA implementation, change control processes, and data integrity initiatives. Cross-functional Support Collaborate with Manufacturing, Quality Assurance, and Process and Analytical Development to align QC readiness with program timelines. Participate in inspections and audits as a QC SME, contributing to responses and follow-ups as needed. Assist in implementing new systems to improve QC efficiency and traceability. In the context of GMP manufacturing facility in totality, support material and facility management, as appropriate Qualifications: Bachelor’s Degree in Cell Biology, Molecular Biology, Biotechnology, or a related discipline 6-8+ years of experience in a GxP-compliant QC environment cell or gene therapy required. Familiarity with phase-appropriate QC systems and regulatory expectations (FDA/EMA, ICH guidelines). Hands-on knowledge of analytical methods relevant to cell therapy, including flow cytometry, ELISA, ddPCR, and viability/potency assays Skills & Competencies: Excellent communication skills, with the ability to clearly convey complex information. Ability to work both independently and collaboratively in a fast-paced cross-functional team environment. Strong organizational and time management skills Team-oriented and resourceful, with strong leadership and communication skills. Committed to quality, integrity, and continuous improvement

Created: 2025-10-07