Monica Avila, MLS (ASCP)

Highly experienced and results-driven Sr. Director, CMC Alliance and Project Management with over 15 years in the biotech industry. I specialize in leading and overseeing critical drug development activities, ensuring GMP compliance, and managing quality across both manufacturing and clinical stages. My expertise is centered on the Chemistry, Manufacturing, and Controls (CMC) functions necessary to advance therapeutic candidates. I have successfully led the tech transfer of four projects from process development to GMP manufacturing for Phase I studies and co-authored technical and regulatory documents for three IND submissions. I am adept at strategic planning and execution, including managing all aspects of the company’s CMC outsourcing activities, creating and reviewing Master Batch Records (MBR), and leading facility and clinical manufacturing teams. My background as a Board Certified Medical Technologist (ASCP) provides a strong foundation for managing quality results and implementing continuous improvement initiatives. Key Areas of Expertise: • CMC Technical Writing & Regulatory Filing (IND) • Clinical Manufacturing Leadership • Project Management & Resource Forecasting • GMP Compliance, CAPAs, and Change Control • Risk Assessments and Gap Analysis