Jonathan Copado Email and Phone Number

• Maintain the analytical laboratory in a state of GMP compliance and inspection readiness, generating positive audit outcomes.• Ensure the scheduling and testing of assigned product line in support of in-process, release, and stability result reporting.• Primary qualified analyst for qPCR, ELISA, HPLC, Cell Based Assays, Mammalian Cell Culture, and Virus Culture.• Track, forecast, and purchase QCA lab inventory, maintaining QCA in a test ready state over 36 months.• Coordinate the on-time calibration, maintenance, and qualification of critical analytical GMP equipment.• Initiate and own Document Change Control activities with experience preparing Standard Operating Procedures (SOP), Analytical Method Documents, Final Reports, and Training Materials.• Lead investigations for Quality Deviations, conducting root cause analysis, and implementing corrective and preventive actions.• Present data trend analysis reports using Excel to support Deviations, Out of Specifications investigations, and Post Release Escalations.• Collaborate with teams of up to 10 departments to own and manage Change Controls for Lab Establishment and Method Transfers• Perform Analytical Validation for ELISA, qPCR, and HPLC methods in compliance of ICH Q2(R1) requirements.• Partner with Analytical Development and OEMs to troubleshoot analytical assays and instrumentation.• Propose cost estimations to senior leadership for the budgeting of QCA Method Transfers and annual routine testing. • Conduct CMC data validation in support of FDA BLA submissions and Information Requests (RFI)• Supported development of Quality Control Analytical lab from Phase 1 to FDA approval of commercial status.

• Oversee daily operation of large scale 100L jacketed reactor systems using Huber Spycontrol Software. • Perform 100L reactor maintenance and repair as needed to maintain production schedule. • Knowledgeable in installation and operational qualification for equipment validation. • Complete understanding of critical tasks, failure analysis, and problem resolution for all operations within the lab. • Develop SOPs and WIs to standardize manufacturing practices. • Thorough knowledge of deviation investigation. • Comprehensive understanding of computerized data entry, material tracking, and purchasing. • Responsible for communication between shifts to harmonize production efficiently. • Support compliance of morning shift technicians to production schedule. • Coordinate complex improvement projects and initiatives with other staff members, as necessary.

• Subject matter expert in all methods of catalog manufacturing within the department.• Performed departmental process development, gathered results, and presented to leadership group.• Authored manufacturing recipes and electronic batch archives for first time production use.• Meticulously recorded data onto physical batch reports in compliance with Good Documentation Practices.• Trained junior technicians in manufacturing processes and techniques.• Maintained manufactured catalog inventory.• Developed organizational methods to harmonize with internal and external customers.• Worked cross-departmentally to identify process needs, requirements, and improvements.• Documented and monitored internal controls to be in compliance with departmental goals.• Manufactured starting material used as the foundation of 2019-nCoV CDC-qualified Probe Kits.

• Accurately and efficiently picked cases to exceed employee productivity standards.• Received and distributed product to sales team.• Coordinated Zones during changeover process.• Performed quality checks of product every hour.• Reworked products that did not meet quality standards