Robert H. Email & Phone Number

Hopewell Junction, Ny, Us

Danbury, Connecticut, United States

-Co-manage a class-leading calibration program consisting of >5000 calibrated devices, instruments and systems in >200,000 ft² GMP pharmaceutical manufacturing, laboratory and research facilities.-Lead continuous improvement initiatives to increase calibration program effectiveness and efficiency, while reducing costs.-Increase client/end-user engagement through the creation, implementation and continued management of a customer-service based web portal for compliance, and equipment lifecycle management services. -Responsible for developing new procedures and the improvement of existing calibration and asset management procedures for greater compliance, effectiveness, and efficiency. -Responsible for site-wide asset management, including equipment onboarding for ongoing laboratory, facilities and manufacturing operations and capital expansion projects. -Lead in-house technical staff, as well as a team of qualified service providers to meet monthly work objectives.-Develop and maintain excellent relations and communications with multiple department leads as well as end-users to manage (planned and unplanned) events, as well as special projects, ensuring maximum efficiency and minimal disruption in a dynamic production environment.-Consistently demonstrate proficiency with multiple software platforms and databases including CMMS and RAM systems.

Pearl River, Ny

-Lead in compliance and support services to Pfizer Vaccine R&D groups including installation, qualification, calibration, planned & unplanned maintenance of laboratory instrumentation, equipment and automated systems.-Optimized laboratory MAC services working with Pfizer management, end-users, suppliers and contractors to meet aggressive schedules to support COVID vaccine development, including multiple BSL2 and BSL3 laboratories. -Increased client/end-user satisfaction by eliminating a long-standing Corrective Work-Order backlog and systematically reducing the response and completion time to set a new standard and expectation for communication, responsiveness and work order completion.-Developed and managed monthly planned maintenance and calibration schedules for a team of technicians to meet Key Performance Indicator metrics.

Greater New York City Area

-Developed analytical testing program and managed analytical personnel and activities including product development, in-process testing and quality assurance testing of cannabis materials and finished products in a highly-functional laboratory utilizing state-of-the-art methodologies.-Ensured that all internal and NYSDOH regulations, quality procedures and standards were in compliance throughout all cannabis product development and production phases.-Developed and maintained a document management program including; Maintenance & Calibration, operation & cleaning and personnel training SOPs. -Developed and maintained in-house asset management & lifecycle systems including equipment Validation and Calibration & Maintenance programs .-Developed and chaired the Safety Committee and developed, implemented and managed an OSHA compliant EH&S / Site Safety Program.

Greater New York City Area

-Developed analytical testing program and managed analytical personnel and activities including product development, in-process testing and quality assurance testing of cannabis materials and finished products in a highly-functional laboratory utilizing state-of-the-art methodologies.-Ensured that all internal and NYSDOH regulations, quality procedures and standards were in compliance throughout all cannabis product development and production phases.-Developed and maintained a document management program including; Maintenance & Calibration, operation & cleaning and personnel training SOPs. -Developed and maintained in-house asset management & lifecycle systems including equipment Validation and Calibration & Maintenance programs .-Developed and chaired the Safety Committee and developed, implemented and managed an OSHA compliant EH&S / Site Safety Program.

-Independent service provider for Equipment Calibration & Maintenance Program management services including: validation (IQ/OQ/PQ), routine calibrations, planned & unplanned maintenance-Specialized in laboratory relocation services, including decommissioning, commissioning and qualification of equipment and instrumentation. -Developed and executed equipment management and compliance documentation including; Creation, review and revision of SOPs, equipment validation documentation and personnel training documentation. -Managed multiple clients and maintained the utmost in compliance, client satisfaction, cost effectiveness and equipment uptime.

-Managed, coordinated and executed facility-wide maintenance program including HVAC, compressed air, purified water system and utilities. -Developed, implemented and managed a compliant validation and calibration program of 400+ pieces of laboratory and precision measurement instrumentation and pilot scale solid dosage process equipment in accordance with (current) FDA, ISO, USP, NIST and ICH requirements.-Authored and maintained compliance documentation such as validation protocols, calibration and maintenance SOP’s.-Managed a DEA compliant site security program to accommodate the processing of controlled substances.-Managed and coordinated facility renovations and capital expansion projects.-Managed the hazardous waste program and EH&S / safety program.

-Managed, coordinated and executed facility-wide maintenance program including HVAC, compressed air, purified water system and utilities. -Developed, implemented and managed a compliant validation and calibration program of 400+ pieces of laboratory and precision measurement instrumentation and pilot scale solid dosage process equipment in accordance with (current) FDA, ISO, USP, NIST and ICH requirements.-Authored and maintained compliance documentation such as validation protocols, calibration and maintenance SOP’s.-Managed a DEA compliant site security program to accommodate the processing of controlled substances.-Managed and coordinated facility renovations and capital expansion projects.-Managed the hazardous waste program and EH&S / safety program.

-Performed installations, validation (IQ/OQ/PQ) and maintenance of analyticalinstruments such as HPLC, GC, UV/VIS and Type 1, 2, and 3, dissolutionsystems for approximately 15 different pharmaceutical companies ranging from fortune 500 companies to independent testing labs.-Performed depot and on-site repair work of various analytical instrumentation/systems.-Performed site/laboratory relocations including decommissioning, movingequipment, and performing re-qualifications of equipment at new site.

-Assisted in Supervising 20 solid dose production and packaging operators in a full-scale cGMP environment. -Performed training of operators on functions for new process & packaging equipment. -Performed troubleshooting and repair of process & packaging equipment in acGMP production environment. -Liaison as an application specialist between R&D and production for scale-up, aNDA bio-equivalency batches and experimental batches.

Performed manufacturing of encapsulated pharmaceutical products using Zanasi/IMA encapsulation machines in a GMP manufacturing environment.Performed cleaning, set-up and preventative maintenance of Zanasi/IMA

Carmel, Ny

-Performed granulation / blending of pharmaceutical products using variousprocess equipment in a GMP production environment.-Performed compression of pharmaceutical products in a GMP manufacturing environment.