Responsible for management of two clinical stability programs

Throughout all my roles I have been responsible for the technical review of vendor deviations, creation and management of CAPAs, ownership of change controls for CMC, management and strategy of commercial and clinical stability programs.Specifically for my role as Associate Director I have:> Vendor oversight for operational improvements in drug substance and drug product manufacturing including validation review and approvals.> Lead commercial technical operations support for quality systems, including change control, deviations, CAPAs, and inspection readiness > Responsible for commercial artwork/labeling management including implementation of new artwork management system

Role Specific Responsibilities include:> Lead commercial technical operations support for manufacturing and process improvements.> Provide input on improvements to existing processes > Assist with validation activities, as needed.

Responsibilities included:> Implementation of new software for managing stability data> Creation and maintenance of product specifications> Updates and Creation of SOPs for Technical Operations as required.

Responsible for deviation investigations, CAPA Implementation and process improvements

Global subject matter expert for TOC applications in the pharmaceutical, nutraceutical, and cosmetics markets. Maintains up to date knowledge of pharmaceutical market trends and regulatory guidance’s including; USP, ASTM, ISPE, and PDA. Primary job responsibilities include:> Generate and train customers and the sales team on technical content and sales tools related to current and new regulatory guidance’s, validation, and cleaning validation.> Present information on industry best practices and new regulatory guidance’s to the global sales team.> Perform seminars and customer training on the use of TOC in cleaning validation and the benefits of real time testing for TOC and conductivity.> Communication with the technical support, global applications team, global sales teams, and customers to solve applications related questions.

Stability product representative responsible for stability study design, data analysis and reporting of analytical product quality data associated with clinical and commercial stability programs. > Regulatory ExperienceAuthoring of stability sections of regulatory filings and compliance documents including Annual Report of Minor Changes, Clinical Trial Applications Commercial Marketing Application Updates and Annual Product Reports> Stability SupportTemperature excursion support for commercially distributed products, out of specification result investigations, change control assessments

Led and supported the validation of equipment, process and cleaning validation on 5 major capital projects. > Program ManagementValidation program manager for Cleaning Validation and Controlled Temperature Units, including implementation of corporate operating standards, performing gap assessments and site implementation plans and updates to site master plans.> Project Management - Cleaning validation for five major capital projects (including 3 new product introductions). Included participation in engineering design reviews, training and oversight of 5-8 contract personnel, strategy development, execution, change control assessments, issue resolution and project closeout - Equipment Qualification of automated equipment. Led column pressure safety project impacting both Colorado sites (using a modified ASTM 2500 approach), managed capital project commissioning and qualification, participated in engineering design, supported qualification efforts for three major capital projects and supported qualification of lab equipment - Led validation to extend the steaming hold times on the WFI and WPU drops in manufacturing - Change control ownership, installation and qualification of CTUs> Regulatory ExperienceSuccessful presentation of cleaning validation and inspection support for FDA, Brazil and EMEA. Wrote sections of the BLA files for two products, participated in inspection responses for EMEA and FDA.> Validation Support and Execution - Process Validation protocol writing, development of key/critical operating parameter tracking tool for manufacturing, study execution and report generation for two products - Managed validation assessments for change controls - Participated in several business activities including: development of a resource allocation tool used to aid in resource assignments for projects, development of the medium to large scale project execution process and back-up project portfolio manager

Improved the quality of the documentation in validation, identified areas for improvement throughout the company and provided engineering assistance as required.- Developed, executed and wrote reports for engineering studies and validation protocols in the following areas; process validation, manufacturing equipment, packaging equipment, cleaning validation, utilities qualification, software validation, packaging validation.- Revised and created job related SOPs as necessary - Reviewed change controls and assessed regulatory impact- Revised manufacturing batch tickets to improve documentation

- Fujifilm (medical device) – Greenwood, SCProject Leader responsible for the qualification of 130 pieces of proprietary chemical manufacturing and finishing equipment, 8 major automated systems and 14 pieces of laboratory equipment with a team of 14 engineers and validation specialists. - Aventis-Behring (pharmaceutical) – Kankakee, ILProject Leader responsible for coordination, tracking and participation in the specification development, protocol development, execution and final report generation for 29 pieces of biopharmaceutical manufacturing equipment.- Schering-Plough (pharmaceutical)– Kenilworth, NJProject Team Leader responsible for coordination of and participation in the protocol development, execution and final report generation for 30 pieces of liquid, cream and ointment packaging equipment. The work was successfully completed in 90 days with a team of 4-5 people. - Purdue Pharmaceuticals LP (pharmaceutical)– Wilson, NC Responsible for the generation, execution and analysis of process validation protocols, cleaning validation master plan, cleaning validation protocols and packaging performance qualification protocols for a solid oral dosage NDA. - Supoprted clients remotely through preparation of design documents, FAT documents and IQ/OQ documentation for packaging equipment

- Wrote and executed equipment qualification protocols, process validation, process verification and cleaning validation. - Managed projects related to process changes and bulk hold studies. - Performed annual product reviews

Wrote and executed equipment qualification protocols, process validation, process verification and cleaning validation for solid oral dosage equipment.

Altus Biologics was a small subsidiary of Vertex Pharmaceuticals that specialized in developing biocatalysts. Responsible for the transfer of processes from R&D to manufacturing. - Scaled-up, optimized and verified processes including solubilization of granular products, chromatography, microfiltration, ultrafiltration, diafiltration, crystallization, cross-linking and drying of enzymes. - Established SOPs for cleaning and operation of processing equipment and new products.