Lester Rodriguez Email and Phone Number

Responsible for leading the Quality organization and for developing a strong quality culture across all Pharma Tech Industries (PTI) manufacturing sites. Accountable for developing and executing quality strategies that support the growth of current product offerings and future pipeline portfolios. Provide management oversight and support to quality teams, ensuring consistency across the company so that all operations meet quality policies and procedures. Responsible for ensuring compliance with all aspects of the Quality Management Systems (QMS). Serve as a key and active member of the Senior Leadership Team, ensuring business objectives are aligned and that the company is performing to operational objectives.

Assured high standards of Quality in all aspects of cGMP compliance. Monitored changes in FDA regulations pertaining to commercial product manufacturing. Provided guidance and direction regarding change control, investigations, deviations, and Corrective/Preventive Actions (CAPAs). Assessed and revised standard operating procedures and identified opportunities to streamline processes and systems. Resolved discrepancies and deviations by following best practices and providing necessary regulatory guidance. Implemented cross functional team to reduce investigation closure cycle time and ensure orders on-time delivery.

Corporate role responsible for overseeing the Quality Control Organization across company manufacturing sites ensuring compliance with current FDA regulations, Good Laboratory Practices (cGLP) and Good Manufacturing Practices (cGMP).

Provided consulting services and solutions to pharmaceutical and medical device companies in the following areas: Quality Management Systems (QMS), FDA Regulations, Manufacturing and Laboratory Investigations, Corrective/Preventive Actions (CAPAs) , Quality Control and Development/Validation of Analytical Methods per ICH Guidelines.Pharma Tech Industries, Royston, GA (10/14 - 12/14)Presented analytical data and analytical methods validations during Pre-Approval Inspection (PAI). Served as Interim QC Laboratory Manager for three (3) months.Patheon, Cincinnati, OH (03/14 - 09/14)Evaluated quality problems (i.e.: CAPA’s and Deviation Reports) and provided thorough and practical assistance in the resolution of process/product non-conformance events. Developed corrective/preventive actions to avert recurrence.Shionogi, Inc., Alpharetta, GA (01/11 - 10/11) Reviewed and evaluated methods development and validation protocols and reports ensuring compliance with ICH Guidelines to support manufacturing process transfer of several Shionogi products. As a commitment to the FDA, authored and provided supplemental information to the Atlanta District to close gaps identified during previous regulatory inspection. Chemence Medical, Inc., Alpharetta, GA (05/10 - 12/10)Served as Interim Quality Control Laboratory Manager for six (6) months.

Managed all Quality Management Systems (QMS) related activities to ensure compliance with regulatory requirements. Ensured systemic quality issues were identified, thoroughly investigated, and resolved at Contract Manufacturing Organizations (CMOs). Addressed customer complaints to ensure systemic issues were appropriately investigated and resolved.

Led the Altea Therapeutics Quality Control department responsible for all Quality Control activities ensuring compliance and the delivery of timely and accurate data and reports. Acted as a mentor for QC personnel, supporting process improvements initiatives and development of innovative, efficient and compliant Quality Systems. Implemented a new data management software system that resulted in significant laboratory performance improvements. Participated on key project teams both within the company and with external product development and contract manufacturing organizations (CMO’s) to discuss and resolve quality related issues. Ensured that project timelines were met and that technical and quality issues were quickly and professionally addressed. Initiated and conducted Out Of Specification/Out Of Trend (OOS/OOT) and discrepancy investigations. Developed, wrote and reviewed a wide variety of cGMP documents. Wrote stability protocols, initiated and coordinated the studies, evaluated the stability data and wrote final stability reports. Compiled and trended analytical data to forecast expiry date. Made pass/fail decisions regarding product release and stability.

Directed the daily activities of 10 formulation technicians. Scheduled the preparation of a wide range of polymer formulations to support the Manufacturing and R&D areas based on production forecast and project timelines. Ensured that appropriate systems were in place prior to product release, including batch record review, proper closure of deviations or discrepancy reports, OOS/OOT investigations and resolution of batch record review related issues. Closely worked with suppliers to resolve supply issues and to order the raw materials and components needed in the formulation area according to weekly schedules and production forecast. Authored and reviewed protocols to support the roll-out of new product processes. Ensured all processes were in control, and provided timely and constructive feedback to peers, support groups and upper management when issues occurred. Initiated and conducted investigations regarding discrepancies during manufacturing of the monomer formulations and wrote Non Conformance Reports (NCR’s). Participated and provided support during internal and regulatory agency audits. Ensured CAPA’s were implemented as identified during audits and evaluated their effectiveness. Initiated, reviewed and approved Change Controls (CR’s).

As a consultant at a leading veterinarian company (Merial), evaluated analytical methods to be transferred to a new manufacturing facility. Established and maintained a strong relationship with both the transfer and receiving manufacturing facilities. Reviewed and evaluated analytical validation data to determine conformance with current ICH Guidelines. Wrote analytical method validation and method transfers protocols and reports. Prepared raw materials specification sheets in compliance to current European Pharmacopoeia (Ph. Eur) and Unites States Pharmacopoeia (USP).

Developed and validated new HPLC, GC and GPC methods. Identified unknown chromatographic impurity peaks. Authored test methods, validation protocols and validation reports. Managed and coordinated the laboratory equipment calibration program. Investigated and resolved issues concerning external and contract sites (i.e. non conformance reports, stability alerts).

Coordinated and managed the re-opening of the Quality Control laboratory in order to support the Manufacturing Department. Directed the daily activities of 10 chemists in the QC laboratory. Managed the analysis of in-process, finished product and stability samples according to production schedules and priorities. Initiated and conducted laboratory Out Of Specification/Out Of Trend (OOS/OOT) and discrepancies investigations. Initiated, reviewed and approved Change Controls (CR’s). Wrote stability protocols, initiated and coordinated the studies, evaluated the stability data and wrote final stability reports.

Evaluated possible new customer’s projects and participated in the weekly planning of workload. Developed new procedures (SOP’s) and protocols. Conducted developmental and experimental work using HPLC, GPC and GC instrumentation, analyzed results and provided technical direction to others in conducting experiments and performing data analysis. Interpreted data to determine meaning within the context of the project, conducted literature searches relevant to existing or anticipated projects. Initiated and conducted laboratory out of specification/out of trend (OOS/OOT) investigations. Directed the technical activities of Scientist I, II and III.

Supervised four manufacturing technicians, outlined work assignments and reviewed work in process. Increased production efficiency by 50%, reduced operation expenses and reduced waste from 15% to 3%. Increased batch yield from 85% to 96%. Participated and contributed in the development of new drugs including liquids and solid dosage forms. Participated in all manufacturing processes including weighing the raw materials, blending, milling and compression of tablets. Performed the reconciliation of all raw materials, components and labels used in the manufacturing area. Reviewed and updated all manufacturing procedures and training records to comply with current GMP's procedures. Ensured that appropriate systems were in place prior to product release, including batch record review, proper closure of deviations or discrepancy reports, OOS/OOT investigations and resolution of batch record review related issues. Closely worked with suppliers and ordered all raw materials and components to be used in the manufacturing area according to weekly schedules and production forecast.

Developed and validated new HPLC, GPC and GC methods. Analyzed raw materials and finished products using a wide variety of USP/NF testing. Generated new forms and new procedures (SOP's). Performed daily test to ensure laboratory instruments were functioning properly. Performed IO, OQ and PQ on new laboratory equipment.

Supervised 42 employees. Ensured production schedules of medical devices were met. Reviewed and approved all manufacturing documentation. Submitted daily production reports to Production Manager detailing production, scrap, and yield. Interviewed, trained and evaluated personnel. Trained new technicians. Coordinated the Receiving Inspection Laboratory transfer from California to Puerto Rico.