Todd Reeves Email and Phone Number

Provide North American region technical support for technology transfers, cost savings projects, manufacturing/packaging process investigations, new product launches, and other technical related support for GSK Consumer Healthcare products produced at external contract manufacturing organizations (CMO's).Conduct onsite support at CMO's for processes improvement, process robustness, investigational, developmental, and process and packaging validation activities.Manage technical documentation required to complete Technology Transfer Dossiers including documents required for regulatory filings. Participate as technical representative in Scoping and Due Diligence visits for new CMOs in North American Region.Provide guidance and training to CMO's in technical risk assessments, validation standards, IOPQ standards, and general GMP standards to ensure they comply with GSK internal standards..

Provide technical leadership in the execution of technology transfer projects supporting the global network strategy in accordance with GSK Tech Transfer Operating Discipline, while sustaining supply and ensuring that GSK quality and robustness standards are met consistently across different sites.

responsible for remediation activities related to product restart after plant shutdown.Responsible for remediation activities for 1st product restart after plant shutdown, successfully re-launching product after successful concurrence with FDA and third party consultant.Develop Product Transfer documents (formula assessments, equipment assessments, Prop 65 assessments, etc.) for transfer of product both into and out of the facility.Writing of Scope Documents and Protocol development, execution, evaluation of data and final reporting.

Global MS&T Scientist for Global Manufacturing Product Sustainment (GMPS) projects; responsible for troubleshooting product issues and providing recommendations for remediation. Proficient in use of Minitab and SIMCA statistical software to evaluate historical data for troubleshooting product issues and development of Design of Experiment (DOE) studies.

Apply continuous improvement methods such as lean manufacturing to enhance the quality, reliability, and cost effectiveness to Semi-Solids manufacturing and packaging processes. Participate in site-wide priorities and lean initiatives across cross functional groups.Execute capital projects.Investigate and resolve production issues, provide technical expertise during investigation process.Development/Updating of Production Master Order and Bill of Material records.

Development of production processes for pharmaceutical products (Solids, Liquids, Suspensions, Creams).Development of production containment processes for High Potency Drug Products.Development/Updating of Production Master Order and Bill of Material records.Writing of Manufacturing Process and Controls Data Reports for Annual Product Reviews.Troubleshooting and investigation of product failures due to manufacturing discrepancies; recommend corrective/preventative actions.Responsible for coordination of development/exhibit/scale-up activities with 3rd Party Customers.Cross functional team member responsible for preparation and review of regulatory submissions.Writing of Scope Documents and Protocol development, execution, evaluation of data and final reporting.

Developed product matrix and equipment matrix to determine approach for cleaning validations.Received an OTC Impact Award for achieving an annual cost savings of ~ $38,000/year for CIP agents.Developed database management system for cleaning validations.Implemented a cross-departmental group to assess cleaning validation gaps and future strategies.Developed Master Cleaning Validation Plan and Cleaning Validation SOP’s (overall strategy for Site).Protocol development, execution, and final reporting.

Supervise, train, and develop team members while managing the Quality Services budget. Review of QCP’s, SOP’s, and product specifications.Effectively managed the testing requirements for launch of four new products in 1st Qtr 2001.Validate and approve product-testing records. Provided overall management of team activities and functions (allocation of resources).Reduced the product testing throughput time by ten days while supervising solids testing team.Performed laboratory troubleshooting/investigation (facilitated, reviewed and approved).

Facilitated investigations and consumer complaints and was responsible for final review and approval. Ensured compliance with cGMP’s. Reviewed and approved labeling for packaging components and Master Shop Orders.Responsible for writing formal departmental operating procedures.

Scheduled analyst’s work that ensured timely product delivery to customers.Accountable for timeliness of stability testing.Involved in method improvements that increased efficiency and timely laboratory testing.Quality Control representative for product integration teams.Accountable for review and validation of other analyst’s work. Used GC, HPLC, titration, TLC, and other general chemistry techniques for product analysis.

Responsible for keeping inventory of culture media.Accountability of quality control for media and instruments.Responsible for monthly maintenance of instruments and related equipment.Performed RPR testing, ELISA testing, MHA testing, and identification and isolation of bacteria.