Project Manager offering a seven year background in complex, full lifecycle project management for high-profile pharmaceutical and healthcare industry projects. Adept in business/technical needs scoping and analysis, with proven success guiding teams in the on-time, on-budget, and on-spec delivery of technology solutions. Successfully manage project budgets (up to $2.4 million per project) and teams (up to 30 cross-functional team members) from initiation through closure.

Broad-based technical expertise encompasses solutions engineering, technical infrastructure, and system/application testing, design, development, and deployment. Skilled communicator able to bridge communication gaps and understand both technical and management points-of-view. Proficient in the development and execution of Computer System Validation documents in FDA regulated environments.

Management Competencies

·         Full Lifecycle Project Management

·         Strategic & Tactical Planning

·         Team Leadership, Training, & Mentoring

·         Time, Personnel, & Resource Optimization

·         Customer Relationship Management

·         Pharmaceutical Industry Systems/Regulations

Technology Expertise

·         System Development Lifecycle

·         Software Testing & Troubleshooting

·         Software Development

·         Computer System Validation

·         Software Design

·         Quality Assurance

Professional Experience

2007 -

Present

DMH Consulting, Inc. Lansdale, PA

Founded the company in December 2007.

1990 -

2007

McNeil Consumer & Specialty Pharmaceuticals (J&J) Fort Washington, PA

Johnson & Johnson Consumer Healthcare Skillman, NJ

LIMS Process Analysis – Lead Analyst

Led cross functional team to deliver LIMS As-Is, To-Be, and Gap Analysis across six Research & Development & Quality Control/Microbiological laboratories within the US, Canada, and Puerto Rico.

·         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 improvement in the areas of processes, people, and technology. Quantified the business benefits of each by cycle time reduction and resource redeployment. Guided management through the opportunity selection process.

Raw Material Impurities – Lead Analyst

Worked with Regulatory and Toxicology in the US and France to automate the collection and retrieval of raw material impurity information, to assess compliance with global legislation and to satisfy increased demand from non-government organizations.

·         Determined project justification and benefits, wrote capital appropriation and obtained management approval.

·         Developed project plan, gathered requirements, developed workflows, and designed the system.

LIMS Statistical Analysis – Project Lead

Led team through the entire project lifecycle to deliver automation of statistical analysis for LIMS data, resulting in 1.5 headcount reduction.

·         Delivered process capability supporting FDA annual product reviews.

·         Delivered stability study trending for R&D, providing early detection of negative stability results.

·         Performed a major upgrade to the enterprise-wide statistical analysis tool, implementing full audit trail for analysis & data.

·         Developed project justification, scope, capital appropriation, budget, risks, vendor contracts, & project plan. Led team through requirements gathering. Directed development & execution of a full suite of validation documents.

Dosage Uniformity Enhancements – Project Lead

Led team through implementation of dosage uniformity (calculations & acceptance criteria) to satisfy mandatory changes to the USP, for four R&D and QC labs in the US and Puerto Rico.

·         Worked with team to identify the impact and document requirements. Developed project plan, budget, and vendor contracts.

·         Led team through reconfiguration of LIMS, updates to product specifications, reports, statistical analysis, and custom code development. Directed creation and execution of a full set of validation documents and test scripts.

System Owner and Facilitator – Technical Manager

Assumed these responsibilities for eight months while co-worker was on leave.

·         Application Owner – Owner of the application portfolio database, employee time tracking system, and IT electronic change request system. Managed support and ongoing change requests and implementations.

·         Compliance – Responsible for company-wide master validation plan and ensuring compliance with corporate IT quality initiatives. Conducted SOP review for the IT Computer Systems Validation processes and identified gaps associated with laboratory systems.

·         IT Security – Provided direct support to company CISO on security issues and initiatives.

·         Coordinated establishment of B2B connectivity to external partners.

·         Supported an FDA general inspection with no observations.

·         Collaborated with R&D on laboratory expansion, identified IT effort and costs.

Human Resources Portal – Project Lead

Led effort through Initiation and Planning phases to provide an internal HR Portal, a repository of HR related information for employees and HR personnel.

·         Developed project justification, scope, capital appropriation, budget, & project plan. Led team through requirements gathering.

LIMS Strategy – Lead Analyst

Participated in a team effort to develop a three year National LIMS and laboratory IT strategy, across multiple R&D and QC sites in the US, Canada, and Puerto Rico. Also,

·         Conducted an internal J&J benchmarking survey of laboratory data systems across ~18 labs.

·         Prepared a LIMS RFP and evaluated vendors, determined costs, timing, & resources for a combined LIMS, ELN, and comprehensive data capture solution.

Statistical Analysis & Trending – Project & Technical Lead

Led team through the entire project lifecycle to eliminate manual data analysis with an enterprise-wide statistical tool, automating the retrieval and analysis of laboratory data, resulting in 2.3 headcount reduction.

·         Delivered trending and process capability for two QC labs in the US and Puerto Rico.

·         Led team through the vendor selection process. Developed project justification, capital appropriation, budget, vendor contracts, & project plan.

·         Wrote the Validation Plan and gathered requirements. Directed development & execution of the remaining full set of validation documents. Participated in vendor audit.

Chromatography Upgrade – Project Lead

Led effort through Initiation and Planning phases to upgrade and standardize multiple versions to the same version, in four R&D and QC labs in the US and Puerto Rico.

·         Prepared project justification, capital appropriation, vendor contracts, budget, resources, risks, and project & deployment plans.

·         Directed preparation of validation plan and requirements.

·         Supported an FDA inspection on chromatography with no observations.

LIMS Packaging Testing – Project Lead

Led team to implement LIMS for package component testing, automating data entry and calculations for an area that was previously processing test results manually.

·         Led team through requirements, design, and implementation of the system, including integration with three types of instruments.

Dissolution Calculations & Transfer – Technical Lead & Software Developer

Led team development of software to pull data from the chromatography system, perform dissolution calculations (immediate and extended release), determine acceptance criteria, and post results into LIMS.

·         Mentored staff on software development processes and techniques.

·         Led effort to gather requirements and fully validate the solution.

Chromatography Implementation – Project Lead

Led a cross-functional team of 28 through the entire project lifecycle, to select and implement a new mission critical chromatography system for 90 instruments and 150 analysts.

·         Led the team through the vendor selection process and obtained mutual agreement between the R&D and QC labs.

·         Prepared project justification, capital appropriation, vendor contracts, budget, resources, and project & deployment plans.

·         Captured $1.3 million in savings through vendor contract negotiations.

·         Established a robust training and support plan to ensure ongoing learning and minimize disruption to the business, that included vendor training, internal resources, and daily & weekly meetings.

·         Directed creation of standardized reports and calculations.

·         Directed requirements gathering and the authoring & execution of a complete set of validation documents. Participated in vendor audit.

·         The Chromatography vendor (Waters) was so satisfied with the project management process that they used this project as a model for future implementations.

LIMS Upgrade – Project & Technical Lead

Led a major LIMS upgrade to provide enhancements and satisfy 21 CFR Part 11, across five R&D/QC labs in the US and Puerto Rico.

·         Prepared capital appropriation, validation plan, & project plan.

·         Performed beta testing on LIMS software. Participated in LIMS data migration.

·         Coordinated purchase of servers and software. Prepared and executed IQ documents and SOP’s. Configured software and databases.

Laboratory Batch Release – Software Developer

Introduced custom software to monitor production batches and, upon batch approval, ensure that associated batches are also approved before permitting batch release.

·         Gathered and documented user requirements.

·         Designed and developed the software and user manual.

LIMS Instrument Interface – Software Developer

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.

·         Developed IQ, OQ, & PQ documents and user manual, conducted training.

Electronic Signature – Software Developer

Introduced custom software to perform electronic signature within LIMS data entry screens and custom code.

·         Participated on companywide team to assess the impact of 21 CFR Part 11 on lab systems.

·         Gathered and documented requirements, designed and developed the software.

LIMS & Chromatography – System Administrator

System administrator for servers in support of development, test, and production environments for LIMS and Chromatography systems.

·         Installed, configured, and maintained hardware and applications/databases. Developed and executed Installation Qualification documents.

·         Ensured optimal system performance by monitoring performance and security, and isolating and resolving operating system and application problems.

·         Prepared capital appropriations for hardware & software upgrades.

·         Prepared and updated Standard Operating Procedures for change control, incident reporting, backup & restore, disaster recovery, and data archive & recovery. Performed regular disaster recovery drills.

·         Negotiated Service Level Agreements (SLA).

·         Installed and qualified an optical jukebox, and developed custom software to archive and restore chromatography data.

1988 -

1990

Temple University

·         System Administrator for systems in support of students and faculty. Configured, installed, and maintained systems. Assisted students in algorithm and software development.

1999

University of Pennsylvania

Master of Science in Computer Science

1990

Temple University

Bachelor of Science in Computer Science, Minor in Mathematics

2004

Johnson & Johnson Standards of Leadership Award – Statistical Trending Implementation

2003

Johnson & Johnson Master’s Complexity Award – Chromatography Implementation

1999

Johnson & Johnson Achievement Award – LIMS Upgrade