Kristin R. Closson Email & Phone Number

Tampa, Florida, United States

Manage the organization of regulated (e.g. GLP, GCP) and non-regulated bioanalytical study programs. Develop and oversee the Project Management, Project Coordinator, and Laboratory Logistic teams. Provide direction and feedback to Laboratory Management and Principal Investigators to ensure sponsor projects are being conducted and completed in a timely and business compliant manner. Manage and monitor laboratory schedule and utilization. Work with Business Development to monitor and project lab capacity. Monitor project budget health. Generate monthly revenue invoices. Provide revenue reports to the Finance team. Main point of contact for client billing queries. Conduct statistical cut point analysis and provide scientific review of Method Validation study data. Write statistical analysis reports. Provide laboratory operations support where needed.

Tampa, Florida, United States

Managed the organization of regulated (e.g. GLP, GCP) and non-regulated bioanalytical study programs. Provided direction and feedback to Laboratory Management and Principal Investigators/Project Leaders to ensure sponsor projects were being conducted and completed in a timely and business compliant manner. Managed and monitored laboratory schedule and utilization. Worked with Business Development to monitor and project lab capacity. Monitored project budget health. Generated monthly revenue invoices. Provide revenue reports to the Finance team. Main point of contact for client billing queries. Provided Oversight to the Laboratory Logistics Team. Conducted statistical cut point analysis and provide scientific review of Method Validation study data. Wrote statistical analysis reports. Provided laboratory operations support where needed.

Tampa/St. Petersburg, Florida Area

Provided general supervision of staff and ensure they completed all assigned work in a business compliant manner. Ensured that employees conducted assigned work and exhibited professional behavior in accordance with employee handbook and human resource policies. Provided training and support to employees with daily activities.

Tampa, Florida

• Designed, developed, validated, and performed bioanalytical assays (large molecule), using MSD and ELISA platforms, involved in pre-clinical and clinical drug development in a GLP/GCP setting. • Experience with anti-drug antibodies, and pharmacokinetics.• Interpreted and reported data to Principal Investigators. • Performed statistical analysis for cut point determination.• Focused on client needs and projected timelines/objectives.• Participated in instrument qualification, maintenance, and training.• Followed good documentation practices per GLP guidelines and applicable SOPs.• Conducted inventory maintenance, monitoring, and receiving of lab materials.• Wrote and reviewed SOPs as appropriate or assigned by management.• Prepared laboratory solutions, reagents, and buffers following standardized procedures.• Monitored laboratory areas for cleanliness.• Performed all duties under minimal supervision.

Whitesboro, Ny

• Designed, developed, validated, and performed bioanalytical assays (large molecule), using MSD and ELISA platforms, involved in pre-clinical and clinical drug development in a GLP/GCP setting. • Interpreted and reported data to Project Leaders. • Performed statistical analysis for cut point determination.• Focused on client needs and projected timelines/objectives.• Maintained calibration of analytical instruments.• Experience with biosimilars, anti-drug antibodies, anti-drug conjugates, and neutralizing antibodies.• Sterile laboratory technique, buffer preparation, use of PPE.

Liverpool, New York

Syracuse, New York

• Maintenance of test organisms such as Fathead Minnows, Ceriodaphnia dubia and Daphnia magna• Conductance of toxicity tests with freshwater and saltwater fish and invertebrates.• Evaluate and interpret data.• Measurement of test solution water chemistry.• Report preparation and other scientific writing. • Training technical staff.• Maintain calibration and good working order of analytical instruments.• Maintained quality assurance and GLP• Prepare, edit and follow SOPs• Oversee technical staff

Rome, Ny

• Completed first seasonal position and rehired to assist in conducting various aquatic research projects throughout New York State focusing on collecting samples on mercury/ PCB/other xenobiotic toxins. • Laboratory and field research• Data entry and analysis• Scientific writing• Investigation of PCB contamination using PISCES • Sediment sampling• Operated small outboard motored boats• Various fish collection techniques such as electrofishing, gill netting, trap netting and sein netting• Weighed, measured and tagged specimens • Maintained cultures of Brook Trout, Brown Trout, and Fathead Minnows used in both field and laboratory toxicity studies.