Lindsey Roberts

With over a decade of experience in quality control and assurance, I specialize in driving excellence in GMP compliance, analytical method validation, and laboratory management. At Umoja Biopharma, I contributed to the establishment of a GMP QC laboratory and supported the production and testing of clinical materials, aligning with the organization’s mission to advance lentiviral vector products to the clinic. My collaborative mindset and detail-oriented approach have enabled me to deliver impactful results while fostering innovation in a dynamic startup environment. At Umoja Biopharma, I played a key role in bringing up a GMP facility, qualifying analytical methods, and ensuring the readiness of the QC laboratory for clinical manufacturing. By leveraging my expertise in equipment qualification (IQ/OQ/PQ) and method transfer, I collaborated with cross-functional teams to meet critical milestones. My prior roles in supplier quality and manufacturing quality assurance further honed my ability to maintain high standards across the product lifecycle.