Summary Innovative project manager and engineer with proven ability to lead, identify, analyze and provide solutions while working in cross-functional teams in a schedule driven environment. Over 10 years of pharmaceutical / biopharmaceutical and medical device manufacturing, validation, quality, regulatory compliance, and project management experience
Education Stevens Institute of Technology, Hoboken, NJ
MS in Pharmaceutical Project Management, December 2011
Bachelor of Engineering in Chemical Engineering May 2003
Skills Regulatory Compliance: 21 CFR parts 211, 820, and 210, GMP, ICH,GAMP5 cGxP, QbD and PAT Knowledge in Pharmaceutical, Medical Device, and Biotechnology Environments
Professional Skills: Quality Assurance, Change Control, CAPA, Project Management, Training, SOP authoring/reviewing, Validation (Equipment, Process, Product, Automated Equipment, Utilities/Facilities Shipping). FMEA, Root Cause Analysis, Project Staffing, Business Development
Software: MS Word, Excel, PowerPoint, Visio, Access, and Project
Language Skills: Spanish – written, spoken
Equipment and Utilities: HPLC and UPLC Systems, HVAC System, Helium Distribution System, Mass Spectrometers, Plate Readers, IEF System, Densitometers, Electrochemliluminescence Detectors, Bioreactors (manufacturing), Cold Chain Transportation Containers, Biological Safety Cabinets, Environmental Chambers (incubators, freezers, cryofreezers, ovens), Packaging and Filling Lines (induction sealers, blister packaging , conveyor belts, capsule fillers, liquid fillers, and labeling machines)
Professional Societies: ISPE, PDA (active member and volunteer for NJ chapter of both organizations)
Professional PSC Biotech, New Brunswick, NJ
Experience Operations Manager 04/12 - present
• In charge of the following projects: Pilot Plan Qualification, Qualification of New Cleanroom, Decommissioning of laboratory equipment, and QA services and support as a dual role:
o Becoming the point-of contact for all needs for the assigned clients/projects (authors statement of work, work-breakdown structures, budgets, and time)
o Project Management for each; ensuring all projects were successfully completed, within budget and on time
• Development and implementation of training program with emphasis on Quality Management Systems, Regulatory overview, Technical Writing and Change Control for all entry level personnel
• Conducts periodic personnel reviews; review of training requirements as appropriate and champions continuous improvement of in-house training by updating training requirements and updating training programs for East Coast Operations
• Creation of the East Coast Intern Training Program with emphasis in Quality Assurance, Validation and Verification, Commissioning, CAPA and Change Control. All interns enrolled in the program have successfully transitioned to billable projects
• In charge of hiring technical personnel for all East Coast Operations
• Business Development – liaison between client and internal project managers as well as industry partners and suppliers
• Technical Resource for execution and QA review for the qualification of bioreactors for biologics manufacturing
• Provides Executive Management with updates on all East Coast Operations, Project Status, and Business Development Activities
• Involved in Supplier Audits for current clients
• Direct supervisor of four (4) validation engineers and four (4) validation interns. Project manager of a total of ten (10) resources
ChemAid Laboratories, Saddle Brook, NJ
Quality Engineer (Contract) 12/11-04/12
• Authored and Implemented Change Control Policy and Procedures as part of the regulatory OTC readiness initiative
• Championed continuous improvement initiatives for the Manufacturing and Technical Support departments to ensure higher level of compliance to FDA and cGMP to ensure OTC readiness in a proposed twelve month period
• Supported development of new PM/Calibration schedules for compounding equipment as well as filling/packing equipment
• Managed CAPA program and supported development of implementation plans by utilizing Root Cause Analysis and FMEA methods to ensure compliance
• Trained and supported personnel for implementation of new programs (Change Control, CAPA, and Validation Execution) as well as company-wide GMP training
• Supervisor of Validation Engineer
Medarex/BMS, Bloomsbury, NJ
Validation Engineer III 04/07-07/10
• Generated change control implementation packages from executed protocols to support timely release of equipment and systems in analytical laboratories and master cell banking areas
• Championed the setup of internal systems for tracking controlled documents as well as qualified parameters. Creation of critical utilities, equipment and protocols matrices that resulted in expedited close-out of projects and Change Controls
• Researched principles of operation and equipment capabilities that supported the development of appropriate change control implementation plans
• Provided guidance to analytical equipment vendors and outside contractors to comply with Medarex Policies and Procedures for GMP and technical issues. Provided customer support with all aspects of validation methodology from protocol development, review of methods/procedures, Change Control, CAPA, and project closeout
• Authored, Executed, and Summarized Validation Protocols and Reports (IQ, OQ, PQ) for Quality Control, Master Cell Bank, Analytical Development, and Pre-Clinical departments in a time-driven environment to ensure compliance
• Executed protocols for equipment, software (including 21CFR Part 11), systems, and utilities in order to meet deadlines for submitting NDA application(s) to the FDA
• Conducted Extensive temperature mapping of approximately twenty environmental chambers, with minimum downtime ensuring uninterrupted operations of the equipment
• Coordinated and Authored Shipping Qualification Plans and Protocols of cryo-shippers to enable transport of cell lines between Medarex sites
• Managed project priorities, worked through project obstacles to successfully complete fifteen projects
• Acted as an Interim Media and Buffer Preparation Supervisor for approximately two months to prevent interruptions or delays with scheduled manufacturing activities due to the lack of personnel during transition of operations to Bristol-Myers Squibb
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