Manage the servivce portfolio for a Global Enterprise account covering calibration, maintenance, service, IQ/OQ/PQ and move activities for multiple labortory locations. Manage Value and Budget creation and adherance. Develop talent and improve global customer service.

Responsible for Strategy and deployment of Global Laboratory Services which create best in class and enterprise wide, compliant standards for equipment and instrumentation calibration and maintenance. In addition, responsible for support services necessary to ensure seamless scientific advancement including flexible staffing, on-site services, supply stockrooms and distribution within sites to lab locations as required. Align strategy within the COE across other Engineering groups to create a uniform lab experience across the J&J enterprise.

Responsible for Procurement related functions supporting the Global R&D and QA Laboratory functions across the Consumer and Medical Device Sectors. These activities include sourcing suppliers, building agreements, developing partnership arrangements, negotiating terms and conditions. Accountable for returning savings to the budget in the form of P&L reductions, avoidance, cost structure savings, and maximizing value across the enterprise.

Support process improvement strategies and associated cost targets across nine manufacturing sites in the MD&D sector. Facilitate training in six sigma, LEAN, and Design for 6sigma across all sites. Maintain, update, report performance and cost saving/improvement metrics to the global sector leadership. Support improvement projects in all sites. Coach and mentor black belt and master black belt candidates to certification.

Develop and Manage Strategy of the group, build consensus for cascade G&Os, manage PDM s for direct reports in EU and US. Support Large Molecule Method Development Group (Biologics), Small Molecule, Analytical COE groups in the Analytical Development Organization.Provide support to the Organization for Strategic Initiatives, such as the deployment of Quality by Design, Lab to Patient, FTE Flexibility principles and tools in all projects supporting the global Analytical Development Organization.Provide representation for Analytical Development on CAPEX team, monitor $8MM in spend.Provide input for Functional budget planning and manage the groups budget, including T&E, Out of Pocket, expense, and operational monies.

Process Excellence Master Black BeltParticipate on and provide input for the Senior Leadership Team.Support product teams for in house, in licensed, and co developed compound development through all stages of product development.Analyze business data, develop conclusions, and build strategy to support development goals of the organization. Analysis includes, developing statistical models, sampling plans, designed experiments, uni- and multi-variant analysis, and criticality analysis.Provide support to the Organization for Strategic Initiatives, such as the deployment of Quality by Design principles and tools in all projects. Facilitate Stage Gate and decision points reviews between senior management and compound development teams

Operations Excellence Black BeltConduct Black Belt Process Excellence* Projects consistent with the plant Business Plan Goals & Objectives. Institutionalize Process Excellence, Design Excellence, and Lean Manufacturing.Educate, mentor, and facilitate all Belts and their projects consistent with the Business plan goals and objectives ensuring that training and certification targets are met.Mentor and consult for various projects and groups in the development of metrics, analysis of process, and enable consistency in metric presentation across the plant.Facilitate PE project identification, selection, and completion across the pharmaceutical plant operations.Conduct training for Yellow Belts, Green Belts, and basic leadership to continue deployment and institutionalization.Maintain Raritan Pharmaceutical Plant Metrics, post results, provide feedback, identify improvement opportunities, and make improvements where possible.

Non Inventory & Capital PurchasingProvide procurement support for Human Resources, Research & Development, Medical, and Quality Assurance organizationsProvide Process Excellence leadership for the Purchasing department including project prioritization and tracking, coaching and application of the DMAIC tools, and scheduling trainingDeveloped and deployed new contract and pricing model for Clinical Research Organizations partnering with McNeil Medical group.Produce Annual cost Savings of $3.1 million in 2001, and $3.3 million in 2002

Manage special projects supporting plant operations. These included process optimizations, validation support, procedure standardization, value stream improvement. Support cleaning validation strategy and deployment. Also responsible for inspection readiness and preparedness, lead tours of facility and operations.

Responsibilities included, process knowledge about all manufacturing centers within the plant, conducting tours for Regulatory agencies, standardizing processes, IQOQPQ and Cleaning Validation process standardization for equipment.

Provide Six Sigma/Process Excellence Leadership for the Fort Washington PlantOversee Qualification and Validation work for Equipment and Facilities to cGMP standardsLead the manufacturing start up and launch build, as well as supply chain integration of Nizoral® OTC shampooIncrease capacity in gel-dipping area by 25%, produced cost savings of $150,000 and capital avoidance of $9 million

Provide technical input to establish compliant processes for current contractorsDevelop compliance strategies and systems for new products in Contract OperationsSupport and execute the compliance objectives as agreed to in the Contract Operations Business PlanParticipate in Due Diligence Assessments for potential license and/or acquisition productsDevelop integration strategy for L&A products within Contract Operations and QA business models

Stability Evaluation, Analytical SciencesCompile statistical data and prepare reports to justify the extension of expiration periodsParticipate on product launch teams and communicate stability testing and sample requirements for new products to meet submission requirementsProvide Risk and Integration assessments to Due Diligence teams for the R&D and marketed product stability aspects of the License and Acquisition of potential new products or dosage forms

Dosage Form Stability TestingPlanning and scheduling of projects and their testingMaintain group sales, solicit new clients, manage quarterly and yearly budgets, as well as forecasting short and long termPrepare and defend capital equipment requests and/or system improvements to raise efficiency of the laboratoryDevelop employees technical and managerial skills through training and education within the performance appraisal system

Supervision of QC laboratory activitiesApprove release of Finished GoodsInvestigate and respond to consumer complaintsMaintain group salary plans, laboratory budget, capital equipment procurement, and instrument maintenance contracts

Antibiotics/Aminoglycosides and StabilitiesDevelopment of new formulations and productsPreparation of ANDA sections and development reportsResponsible for the manufacture of clinical, scale-up, submission, and launch quantity batches of productsDevelop and validate new manufacturing processes and analytical methods

Test and release of raw materials and finished product per USP and NDA requirementsPerform New York State EPA facility water testsPerform long term stability tests for products and prepare APR data

Isolation and sequencing of viral RNA from various viral culturesDevelop labeling and screening methodologies for RNA fragmentsProduce and maintain stock antigen cultures for the North American Foreign Animal Disease Antigen Bank. Send stock cultures to outbreak points throughout the world as neededPerform in-vitro vaccine assessments through compliment fixation testingStudied interaction of Mycoplasma inherent contamination on virus and vaccine mechanisms

Maintain various primary cell line cultures and support mediaPrepare original cell lines from primary organs and tissuesProduce and maintain virus cultures for research purposesPrepare vaccines and execute test protocols