Misty DeRiggi
Harrison City
Summary
Biospecimen Project Manager with 20+ years of experience in clinical research and laboratory operations. Expertise in biospecimen lifecycle management, clinical trial execution, and maintaining data integrity. Strong background in cross-functional coordination, regulatory compliance, and laboratory systems. Proven ability to manage complex studies, streamline processes, and deliver high-quality results in fast-paced, demanding environments.
Overview
21
21
years of professional experience
Work History
Biospecimen Project Manager
LabConnect
05.2024 - Current
- FSP solutions supporting Amgen clinical trials
- Concurrently manage end-to-end biospecimen lifecycle activities from sample receipt through analysis and final disposition for 13 clinical studies
- Maintain accurate specimen metadata and resolve discrepancies to ensure data integrity and regulatory compliance
- Coordinate specimen updates and communicate study status to clients, stakeholders, and cross-functional teams
- Create and maintain complex study sample trackers
- Oversee data transfers and analytical data management between internal and external laboratories
- Review clinical study protocols, scopes of work, and sample processing requirements to support study execution
- Monitor specimen receipt status, assay timelines, and completeness of laboratory data for database lock readiness
Lead Specialty Laboratory Technologist
UPMC Hillman Cancer Center
12.2011 - 05.2024
- Managed up to 10 concurrent clinical trials (Phase I-IV and pre-IND) from initiation through closeout
- Directed biospecimen management operations of blood and tissue from receipt through disposition of final product ensuring chain of identity and chain of custody compliance
- Supervised and trained a team of 10 specialty technologists, including onboarding, competency assessments, and performance management
- Coordinated cellular therapy manufacturing schedules in collaboration with clinical trial investigators and treating physicians
- Conducted quality assurance review of patient batch records for completeness, accuracy, and compliance with SOPs and regulations
- Led key quality improvement activities including: Quartzy implementation for inventory tracking and ordering, competency program redesign, and deviation management system rollout
- Played a key role in lab relocation (2020), including cleanroom design, setup, furnishing with necessary lab equipment and subsequent equipment qualification (IQ/OQ/PQ)
- Led design and implementation of LabTrac LIMS system for specimen tracking and management
- Supported FACT and CAP accreditation processes, including inspections, RFI, and corrective actions
Medical Technologist I
UPMC Hillman Cancer Center
07.2007 - 12.2011
- Cellular therapy product preparation for clinical trials in a GMP clean room setting utilizing aseptic technique. Includes cell culture, co-culture with various antigens, peptides, and autologous HIV-1 virus, cell product thaw, wash, and final formulation for infusion.
- Assay performance including ELISA, TCID-50, PCR, mycoplasma and endotoxin detection, surface and intracellular flow cytometry staining, acquisition and resulting using the Beckman Coulter FC-500 and BD Fortessa cytometers.
Specimen Technician II
Quest Diagnostics
07.2005 - 07.2007
- Job duties included quality control for all departments, specimen acquisition and accessioning, handling of irretrievable specimens, customer service, and problem resolution.
Education
Bachelor of Science - Biology
West Virginia University
Morgantown, WV01-2005
Skills
- Able to stay on task and organized while managing multiple competing priorities with deadlines
- Able to prioritize and multitask, learn and adapt quickly, and work efficiently independently and in a team setting
- Exceptional communication and interpersonal skills and ability to develop strong working relationships
- Proficient in Microsoft Office applications
Publications
Manufacturing and validation of Good Manufacturing Practice- compliant regulatory dendritic cells for infusion into organ transplant recipients. Cytotherapy, 2023-04-01, Volume 25, Issue 4, Pages 432-441
Timeline
Biospecimen Project Manager
LabConnect
05.2024 - Current
Lead Specialty Laboratory Technologist
UPMC Hillman Cancer Center
12.2011 - 05.2024
Medical Technologist I
UPMC Hillman Cancer Center
07.2007 - 12.2011
Specimen Technician II
Quest Diagnostics
07.2005 - 07.2007
Bachelor of Science - Biology
West Virginia University