Clerisse Lardieri
Philadelphia,PA
Summary
Philadelphia-based biotech professional with 6+ years of experience in cell therapies, cell banking and viral vector manufacturing. Experienced with managing manufacturing operations and leading production teams. Utilizes expertise in process improvement to optimize workflows and enhance productivity. Knowledge of quality control and team leadership to maintain high standards and meet organizational goals.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Clinical Manufacturing Supervisor- Viral Vector
Minaris Advanced Therapies
Philadelphia, PA
12.2023 - 03.2026
- Oversees, mentors, and manages performance of others on manufacturing processes and methods to identify gaps and implement improvements.
- Drives sourcing and purchasing of standard, new and complex equipment
- Address and improve complex cGMP compliance and regulatory gaps/issues
- Interpreting data and draw conclusions for internal and external communications to recommend path forward for processing
- Accountable for schedule preparation, forecasting, adjustments and performance of work assignments for team to ensure adequate staffing across assigned programs
- Reviews SOPs, Batch Records, and technical documents including NCE/deviations
- Collaborated with cross-functional teams to achieve production goals and optimize workflow.
Manufacturing Associate I-Lead Manufacturing Associate
WuXi Advanced Therapies
Philadelphia, PA
06.2019 - 12.2023
- Assists in bringing custom vector clients to Manufacturing by collaborating with Process Development in technical transfer to ensure manufacturability with single use closed systems and training
- Adhered to current Good Manufacturing Practices (cGMPs) in activities including: operation and maintenance of equipment, solution and material preparation, understanding of manufacturing processes and methods
- Conducted quality control inspections to maintain product standards and compliance.
- Authored and revised Standard Operating Procedure revisions, Batch Records, and Solution Preparation Records as needed
- Provided training and operational guidance in manufacturing processes to newer employees
Education
Some College (No Degree) - Biology
West Chester University of Pennsylvania
West Chester, PASkills
- Lenti/AAV upstream training specialist
- Bioreactor subject matter expert
- Chromatography and filtration expertise
- Cultivating leukopaks for clinical applications
- Proficient in problem analysis
- Project oversight experience
- Experienced in Lean Six Sigma principles
- DMAIC methodology expertise
- Quality assurance
Certification
Lean Six Sigma White Belt
Timeline
Clinical Manufacturing Supervisor- Viral Vector
Minaris Advanced Therapies
12.2023 - 03.2026
Manufacturing Associate I-Lead Manufacturing Associate
WuXi Advanced Therapies
06.2019 - 12.2023
Some College (No Degree) - Biology
West Chester University of Pennsylvania