Director/Sr. Director, Analytical Development & Quality Control

• Grows the analytical and quality departments by attracting, training, engaging, and retaining talent.
• Leverage regulatory guidance and Quality-by-Design
• Evaluates production operations from a strategic level
• Collaborates with management and senior staff across production departments
• Selects, develops, and qualifies phase-appropriate test methods for the characterization of HSV and Synthetic oncolytic viruses
• Responsible for environmental monitoring program for GMP manufacturing
• Collaborates with purchasing manager to ensure raw materials from external suppliers meet quality requirements
• Assesses test results and approve recommended changes
• Reviews quality control documentation such as SOPs, logs, and reports for effectiveness, accuracy, and relevance
• Authors SOPs, method and instrument qualification protocols, reports, certificates of analysis, and CMC sections of regulatory filings
• Serves as a subject matter expert and aiding in the investigation of out of specification or out of trend analytical results
• Interfaces with contract research organizations (CROs) and collaborators to lead method transfer and method qualification activities

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.