Projects

Following are examples of our relevant experience:

• Validation Lead for a LIMS implementation in multiple QC laboratories. Developed the validation plan, installation (IQ), operational (OQ), and performance qualifications (PQ), test scripts, and trace matrix.
• Executed test scripts for operational verification of a new chromatography system in Drug Development.
• Led team through a major LIMS enhancement to dosage uniformity calculations and acceptance criteria, for multiple R&D and QC labs. Developed the project plan, budget, and vendor contracts. Led team through effort to identify impact of the change; document requirements; make the necessary changes to product specifications, reports, statistical analysis, and custom code; and full validation.
• Responsible for company-wide master validation plan and ensuring compliance with corporate IT quality initiatives. Conducted SOP review for all IT Computer Systems Validation processes and identified gaps associated with laboratory systems.
• Led team to deliver LIMS As-Is, To-Be, and Gap Analysis across six R&D, Quality, & Microbiological laboratories. Collaborated with over 30 team members to collect the current state process within raw materials, stability, support of marketed products, new product development, microbiology, process & method validation, formulations, and packaging materials. Identified ~ 25 specific opportunities for processes and technology improvement and quantified the business benefits of each.
• Application Owner for the IT Change Request system. Managed enhancements, support, and implementations.
• Led team to deliver automation of statistical analysis for R&D and Quality labs resulting in 1.5 head count reduction. Led team from concept through closure, including requirements gathering and system validation. Delivered process capability supporting automated FDA Annual Product Reviews for all manufactured pharmaceutical products. Delivered stability study trending for R&D, providing early detection of negative stability results. Provided full audit trail for analysis & data.
• Participated in a team effort to develop a three year laboratory IT strategy, across multiple R&D and QC sites in the US, Canada, and Puerto Rico.
• Prepared a LIMS RFP and evaluated vendors, determined costs, timing, & resources for a combined LIMS, ELN, and comprehensive data capture solution.
• Led effort through Initiation and Planning phases to upgrade and standardize a chromatography system, in multiple R&D and QC labs in the US and Puerto Rico. Directed preparation of validation plan, deployment plan, and requirements.
• Led team from concept through closure to eliminate manual data analysis with an enterprise-wide laboratory data mining and statistical analysis tool, resulting in 2.3 manpower savings.
• Delivered data trending and process capability supporting automated FDA Annual Product Reviews for all manufactured products.
• Led team through a vendor evaluation & selection process to select a laboratory Statistical Analysis package to integrate with LIMS.
• Participated in vendor audits to ensure compliance with FDA regulations such as 21 CFR Part 11.
• Supported numerous FDA inspections for LIMS and Chromatography systems.
• Led team effort to develop custom software to extract chromatography results, perform dissolution calculations (immediate and extended release), determine acceptance criteria, and post results into LIMS. Led effort to gather requirements and fully validate the solution.
• Led a team through a vendor evaluation & selection process to select a new chromatography solution for R&D and QC labs, for 90+ instruments and 150+ analysts.
• Led a cross-functional team of 28 through the entire project lifecycle, to implement a new mission critical chromatography system. Prepared project justification, vendor contracts, budget, resources, and project & deployment plans. Captured $1.3 million in savings through vendor contract negotiations. Directed requirements gathering and the authoring & execution of a complete set of validation documents. Minimized disruption to the business through development of robust training and support plans.
• Developed custom software within LIMS to ensure each batch was released only after approval of related batches. Gathered and documented user requirements. Designed and developed the software and user manual.
• Led a major LIMS upgrade to provide enhancements, satisfy 21 CFR Part 11, and migrate data, across five R&D/QC labs in the US and Puerto Rico.
• Participated in LIMS & database configuration, custom software development, and data migration.
• Participated on company wide team to assess the impact of Part 11 on laboratory IT systems.
• Introduced custom software to perform electronic signature within LIMS data entry screens and custom code, ensuring compliance with the 21 CFR Part 11. Gathered and documented requirements, designed and developed the software.
• Introduced custom software to transfer assay, dissolution, and content uniformity data from UV/Vis instruments directly into LIMS. Gathered and documented user requirements. Designed and developed the software. Also developed IQ, OQ, PQ, user manual, and conducted training.
• Collaborated with R&D on a major laboratory expansion project. Identified IT & CDS effort, costs, and plan.
• Developed Standard Operating Procedures (SOP) for for application use, support, and maintenance, for such areas as backup/recovery, archive, system administration, system usage, change control, problem escalation, and incident reporting.
• Administered LIMS systems in support of R&D and QC labs at multiple sites. Collaborated with business partners to gather & analyze requirements. Managed incoming change requests, determined cost and time estimates, and implemented approved changes to applications and databases as required, such as enhancements, code changes, reports, calculations, database & configuration changes, and software upgrades and patches.