Supervise, schedule tasks and mentor Scientists and Lab Technicians within the Analytical group Manage the progress of multiple projects to meet projected deadlines Function as SME and trainer on general molecular biology methods associated with cloning, PCR, gel electrophoresis, viral potency assays, cell-based assays, ELISA, protein analytical assays, HPLC, and virus/vector propagationLead the transfer and adaptation of product-specific assays provided by clientsLead the development, validation and implementation in QC space.Present and defend data both internally and externally in clients facing meetingsSuccessfully field client questions and requests.Implement continual improvement of assay testing procedures, data analysis tools and cost-effectiveness of processesOversee the maintenance of engineered cell linesPerform work in a BSL-1, -2, or -3 environment as needed to support analysts.Review and approve data packets from upstream and downstream processes and analytical assaysOrganize and manage laboratory inventory including the creation of project specific BOMs and the procurement of supplies and materials needed for protocol executionWrite SOPs, work instructions, test methods, material specifications, and other PD documentsResponsible system owner (RSO) for key analytical equipment

Lead and manage non-routine projects to completion within a set timeline in a high paced changing work environment.Communicate with customers, laboratory analysts, interdepartmental supervisors and group leaders on non-routine projects.Successfully field unsolicited request for projects by generating quotes, execute feasibility studies and create scope of work documents, protocols and testing plans.Peer review and authorization of SOPs on Master Control.Present scientific information to management and stakeholders.Provide support and training to technicians and microbiologists in the laboratory.In charge of innovation and automation efforts for the microbiology department.Act as compliance officer during external and internal audits.

Research and development of allergen detection kits.Maintain detailed records of procedures.Design and execute experiments with the goal of introducing a finished product into the market within a set timeline.Keep up-to-date on current literature and techniques.Write and revise SOPs for insertion in working instructions for products.Present and defend data on internal and national meetings.

Manufacturing of two vaccine products, one based on a select agent.Responsible for the quality control, sterility assurance, potency and toxicity testing of the two vaccine products.Revision and execution of SOPs.Maintenance and implementation of GLPs and GMPs.Registered Responsible Official (RO) with the CDC Federal Select Agent Program for the facility.Oversea environmental monitoring, water testing of the facility and overall maintenance of compliance with governmental regulations including the FDA and CDC.Maintenance and repair of laboratory equipment.Perform update and maintenance of the company bacterial collection. Prepare internal quality control panels for various departments.

Maintained laboratory compliance with university regulations. Provided expert advice on techniques and experiment troubleshooting. Ordered laboratory materials and maintained laboratory spaces clean.