Karen M. Crow

About Karen M. Crow

Highly motivated microbiologist with expertise in a wide range of laboratory and…

Experience

1. Senior Manager, Microbiological Sciences - Validation and Studies

   Regeneron

   Apr 2019 — Present

   Responsible for the initiation of a new branch within the department coordinating support for method and equipment qualifications, organism evaluations and studies related to new equipment. Developing analyst qualification program for media fill reads. Oversee new microbiological lab expansion project, including isolator, autoclave, utility and cleanroom qualifications, including supporting cycle development studies. Managing selection, qualification and implementation of room temperature media for environmental monitoring. Expanding organism evaluation program for microbial risk assessments and trending. Review and approve specifications for new molecules and ICH stability programs for microbiological testing. QC liaison for drug product testing and investigations performed at contract manufacturers. Support development and implementation of WFI hose study across sites. Established internal and cross functional laboratory audits to drive understanding of processes, documentation and similarities related to data integrity and compliance. Responsible for the design of disinfectant efficacy (DE) and low endotoxin recovery (LER) studies with the implementation of governing procedures. Perform compendial review against current procedures to ensure compliance; establishing new procedures to support timely compendial update review and provide training of cross functional teams where processes overlap departments

Education

• Rochester Institute of Technology

  Quality Certificate

• University of Rochester

  BS, Microbiology and Immunology

• Finger Lakes Community College

  Associate’s Degree, Chemical Laboratory Technician

Skills

• Laboratory
• Technology Transfer
• Laboratory Information Management System (Lims)
• Trackwise
• Aseptic Processing
• Gmp
• Manufacturing
• Quality Assurance
• Laboratory Skills
• Microbiology
• Capa
• Lifesciences
• Six Sigma
• 21 Cfr Part 11
• Process Improvement
• Lims
• Regulatory Affairs
• Validation
• Fda
• Environmental Monitoring
• Biotechnology
• Standard Operating Procedure (Sop)
• Sop
• Cross-Functional Team Leadership
• Change Control
• U.s. Food and Drug Administration (Fda)
• Testing
• Gxp
• Team Management
• Biology
• Quality Control
• Glp
• Analytical Chemistry
• Biological Sciences Data Deviations
• Pharmaceutical Industry