Responsibilities have expanded to Continental US & Puerto Rico.

Cell & Gene Therapy Unit

• Maintains all qualified equipment & systems in compliance with policies, guidelines and procedures.• Performs calibration, equipment qualification and validation activities of Analytical, Bioanalytical, and Cell Line Development equipment. • Performs maintenance, repair, and troubleshooting of Analytical, Bioanalytical, and Cell Line Development equipment. • Develops change controls, validation plans, qualification protocols, associated reports and procedures. • Standardization of Blue Mountain and eWorks calibration databases.• Executes equipment qualifications, validation protocols, and process improvement studies. • Conducts investigations into deviations and qualification failures, and develops and implements corrective and preventive actions. • Contracts with and supervises vendors for qualification and metrology functions. • Develops and reviews written procedures for calibration and preventive maintenance of equipment. • Coordinates laboratory equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area. • Provides guidance to internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates. • Manages / supports facilities new construction and relocation projects. • Completes and reviews all calibration, qualification and validation documentation for accuracy, completeness and compliance to Celgene standards. • Technical knowledge and direction as Laboratory Systems Management site representative during interactions with all cross functional groups, as required. • Regularly reviews, prioritizes and respond to customer equipment qualification and support requests. • Provides technical support and guidance on calibration, equipment qualification and validations issues. Interfaces with customers to ensure all expectations are being met.

* Supervise and monitor the testing and performance of calibration personnel dedicated to calibrating various process instruments throughout the site.* Coordinate and ensure timely completion of both scheduled and unscheduled calibration and preventitive maintenance.* Evaluate instrument nonconformances and consult with department representatives for disposition.* Train calibration personnel on internal SOP's and monitor staff training to ensure compliance.* Process calibration work requests and approvals as needed in computerized calibration management system.* Develop Finite Schedule for technicians and vendors* Oversee and develop processes and SOP's for the insourcing of equipment and lab standard calibrations.* Develop and review departmental budget for Capital and Low Value Asset purchases.* Evaluate employees for annual merit based raises/bonuses.

• Direct the operation of the facility regulatory asset management program (Blue Mountain): Maintain the database, ensuring completeness and accuracy of all data; manage user account creation and status; audit the system; and manage system maintenance and upgrades.• Developed Dendreon Corporate Sterility program for testing clean rooms and biological safety cabinets.• Developed Chlorine Dioxide Decontamination program for Dendreon. • Manage calibration and preventative maintenance activities; schedule activities coordinate execution, and verify work completion, documentation completeness, review and approve.• Perform equipment and instrument calibrations, such as temperature, pressure, time interval/rotation, on incubators, refrigerators, freezers, centrifuges, room environments, water system, balances, particle counters, biosafety cabinets and laboratory equipment.• Oversee communication of system performance and maintenance to operating departments; write exception reports for alarms, calibration and other deviations from operational requirements.• Verify training qualifications and status of all personnel performing calibration, preventative maintenance or repairs; ensuring personnel are fully trained before performing work.• Operation of Building Management computer system (BMS); run trend reports and compilation of monthly trend graphs for all cGMP equipment tracked by BMS; as well as reconciliation of daily alarm reports.• Author and revise facility/engineering SOPs.• Structure Training program for Clean rooms and Biological Safety Cabinets for all 4 Dendreon Facilities • Structure month to month Finite Schedule.• CETA (Controlled Environment Testing Association) Member / Site Contact • Train and oversee contractor’s for engineering projects• EH&S Team Member as well as First Responder for site First Aid Team

• Member Evolution Scientific, Inc., Quality Committee• Technical Expert, Registered with Nuaire Biological Safety Cabinets.• Technical Expert / Trainer on IEST, 209E, NSF, CETA, OSHA and ISO 14644 regulations.• Author and review Standard Operating Procedures for Certification / Calibrations Services as well as review Validation Protocols pertaining to the same.• Designed and constructed training area for technician training on Biological Safety Cabinets, Laminar Flow Clean Benches, and Chemical Fume Hoods.• Provide training seminars as well as hands on training to new technicians• Hiring of necessary departmental employees • Calibration, preventive maintenance and troubleshooting of assorted freezers, incubators, centrifuges, Getinge Washers, Getinge Autoclaves and AMSCO/Steris VHP generators• Particulate testing of compressed air and nitrogen lines.• Spore strips used for reduction testing in decontaminations.• Electronic troubleshooting of Biological Safety Cabinet and Fume Hood Alarms.• Experience with various equipment; thermoanemometer, manometer, particle counter, photometer, velgrid, flow hood, Fluke • Trainer on the latest version of the CDC and NIH regulations• Experience servicing GMP and R&D areas• Knowledge of aerosol fill, powder & solid form production

• Site Supervisor between Micro-Clean, Inc. and all PA/NJ Merck sites.• Lead technician on shutdowns for AstraZeneca and MTF. • Extensive electronic troubleshooting of Biological Safety Cabinet wiring harnesses, circuit boards, motors, speed controller’s and capacitors.• Large area Biohazard decontamination training and experience• Biological Safety Cabinet decontamination training and experience.• Involved with company training of FDA field agents at Micro Clean, Inc. facility.• Spore strips used for reduction testing in decontaminations. Plating experience in BL2 and BL3 labs• VHP generator operation / certification experience.• Electronic troubleshooting of Biological Safety Cabinet and Fume Hood Alarms.• Training in “Air Balancing”.• Testing of various HEPA filtered devices; Biological Safety Cabinets, Clean rooms, Air Handlers, Vacuum Arms, Isolators, and Glove boxes using a Laskin Nozzle or Thermal Generator containing Emery 3004.• Respirator trained: (Negative Face Respirator, PAPR, & SCBA)• Trained on OSHA regulations that pertain to the Pharmaceutical / Medical Industry.• Trained on the latest version of the CDC regulations• Experience servicing GMP and R&D areas• Knowledge of aerosol fill, powder & solid form production.