Cynthia M Lydell

Molecular Laboratory Operations

• Serve as a Supervisor in a team of 90 Biopharmaceutical Manufacturing Associates performing Biosafety and CMO testing.
• Adhered to cGMP practices, lead investigations, participated in the writing of Events responding to audit findings and implementing CAPAs.
• Responsible for generating weekly and monthly metrics to include tracking performance, schedule adherence, time management, safety, quality and product release.
• Developed employees through Performance Development Plans, training, continuous feedback and Evaluations.

• Performed laboratory experiments to support the Blazar Platform FAST MAP-HAP Rodent Panel and launch of the CHO AOF Virus Panel, screening assays for Biosafety testing for adventitious agents. Including but not limited to RNA spike extractions, multiplex PCR and Fragment Analysis Sequence Testing using automated methods.
• Experience with QIAGEN nucleic acid extraction equipment, Eppendorf Liquid Handlers, and Applied Biosystems 3500xL Genetic Analyzer.
• Quality Assurance documentation review of SOPs, Batch Records and Forms . Use of the BRIQS Trackwise system for General Change Control and Event reporting.
• Provide logistical support managing laboratory equipment, maintenance and validation serving as liaison with internal and external parties to ensure cGMP compliance.
• Procurement for laboratory services, equipment, consumables and expense management .

• Epidemiological Surveillance of foodborne pathogens in the Commonwealth of Virginia, with direct support and communication with the Virginia Department of Heath and the Center For Disease Control and Prevention.
• Daily testing of patient samples using Pulse Field Gel Electophoresis (PFGE) and Whole Genome Sequencing (WGS) platforms.
• Data analysis using Bioinformatics software to monitor cluster activity with real-time reports to local and national agencies.

• Supervised staff of 30 Biopharmaceutical Manufacturing Associates in a Large Scale Manufacturing laboratory.
• Responsible for managing the daily operations in a 24 hour facility to support our Manufacturing customers, Upstream and Downstream, by serving as a support department producing various reagents needed for cell biology growth and protein purification.
• In a high paced environment, facilitated urgently needed requests from our customers and adjusted the schedule and staffing to ensure deadlines are met, preventing deviations.
• Adhered to cGMP practices, lead investigations, participated in the writing of Deviations and CAPAs.
• Responsible for generating weekly and monthly metrics to include tracking performance, schedule adherence, safety, quality and product release.
• Developed employees through Performance Development Plans, training, continuous feedback and Evaluations.
  

• Served as a Bacteriology SME under the MID-BRR (NIAID) contract.
• Responsible for the production and authentication of a wide variety of Bacterial products
• Wrote, reviewed and edited SOP's, Work Instructions and documentation to consistently improve processes.
• Support ATCC Custom Commercial Orders by assisting Project Coordinators in securing customer contracts and performing the experiments such as Bacterial identifications and in-activations, Limit of Detection (LOD) assays, and genomic DNA, lipid and protein extractions.
• Experienced in the propagation of Influenza in embryonic eggs.
• Initiated an interdepartmental cross-training program among the scientific disciplines.
• Adhered to GMP/GLP regulations and ISO standards.

• High Containment Biomaterials Team (HCBT). Supervised a staff of up to 8 employees in the High Containment Facility of Bacteriology, Virology and Molecular Biology disciplines focusing on the research, production and authentication of BSL 2 select agents, BSL 3 organisms and corresponding reagents.
• Managed the work flow for each Biologist using an ERP based system and reviewed batch records for scientific and quality content.
• Performed quality control through genotypic and phenotypic methods to include biochemical testing, automated identification systems, PCR based methods and DNA sequencing.
• Participated in extensive annual safety and security training and maintained DOJ clearance to work with Select Agent Material.
• Complied with and enforced all ATCC corporate policies and procedures, and USDA and CDC regulations and guidelines.

• Provided Technical Support for a Microbial Identification and Phenotype Microarray system via phone, email, Web conferences and on-site visits to National and International Customers requiring 2-3 weeks per month of travel. Maintained detailed logs of Customer service provided.
• Performed the installation, training, and hardware and software troubleshooting for the Microbial Identification and Phenotypic Microarray systems. Responsible for the Preventive Maintenance, Validation, selling of Service Contracts and repair of Biolog equipment.
• Lead a bi- monthly Training Workshop at Biolog for National and International customers focusing on product introduction, laboratory setup, software analysis and troubleshooting.
• Provided training and support to International Distributors of our product on-site in the United States, Europe and the Middle East.
• Responsible for the drafting and editing of SOP's, Technical Bulletins, Software and Hardware User's and Validation manuals.
  
• Conducted research experiments on our product as required.

• Responsible for the propagation, production and authentication of a wide variety of organisms deposited with the Bacteriology Collection.
• Experienced in biochemical, phenotypic, and molecular characterization techniques.
• Genomic DNA preparation and authentication from a diverse group of bacteria.
• Experienced in the proper handling procedures of Select Agent microorganisms in BSL 3 laboratory.
• Provide technical support for the Bacteriology collection to internal and external users through telephone and email inquiries.
  
• Field Research Experience
  Served as the project coordinator for a salt marsh biotic survey in Eastern Coastal Virginia conducting a temporal and spatial biotic survey of the bacterial population; maintained sample and data for participating institutions.