Microbiologist, career comprising continuous academic distinction and recognition for performance excellence; expert in GMP production, process development, scaleup, and improvements to commercial GMP processes; skilled in resolving complex issues where analysis of situations and data requires an in-depth analysis of process data gained from multiple sources; experienced in various USP testing and reporting; consummate technical writer, facility operations, and internal process leader in establishing metrics and making recommendations to the management team; practiced in training and mentoring superior teams that consistently produce successful results; accomplished in fostering lasting, trusting relationships with high-performing, cross-functional teams; proficient in Microsoft Office Suite and Laboratory Information management systems (LIMS); adept in managing multiple projects in fast-paced, dynamic biopharma environments.
Key Competencies & Skills:
• PCR, Cloning, Gel Electrophoresis Expertise
• OOS Investigation & CAPA
• Team Building & Training
• USP methods <51>, < 61>, and <62> Testing
• Microbiology, Molecular Biology, & Lab Mgmt
• Relationship Building & Management
• Data Analysis & Interpretation
• Strong Listening & Communications Skills
• Results‐Driven Management
• Process & Continuous Improvement
• Superior Internal/External Project Mgmt Skills
• Strong Thinking/Problem Solving
• SOPs, Quality & Regulatory Documentation
• Process Design & Scale‐Up
• Excellent Organizational Skills
• GMP, EPA, and USP Compliance
• Team Mentoring & Management
• Regulatory Audit Support
