Mark Clemente Email & Phone Number

New York, Ny, Us

New York, Ny, Us

Paris, France, Fr

-Provide engineering quality review services to CAPEX projects and operational support activities. Provide leadership of the C&Q activities and assigned support team for select projects and/or production areas. This includes activities such as scope development, resource and cost estimation, execution planning, scheduling, tactical execution, troubleshooting and resolution of discrepancies, tracking / reporting, documentation review / approval, and audit support of the C&Q process and the resulting deliverables.-Ensure consistent application, governance and maintenance of site Commissioning and Qualification (C&Q) platform procedures, application of C&Q testing templates, and engineering standards / specifications on projects (both OPEX and CAPEX). Participate directly in development and execution of the C&Q deliverables.-C&Q Lead for two BARDA-funded site projects which include the construction and validation of a new adjuvant manufacturing suite, and the retrofit of an existing GMP facility to support the development and manufacturing of an adjuvanted pandemic influenza vaccine.

Paris, France, Fr

Provide general facilities and equipment support for the Sanofi Pasteur R&D facilities in Swiftwater, PA; Cambridge, MA; and Orlando, FL as part of the Global R&D Operations - Facilities, Equipment, and Laboratory Support platform.

Paris, France, Fr

-Building manager for three site facilities which house 45 BSL-2/2+/3 labs, office areas and mechanical support spaces. Manage ~$1.25m annual capital expense budget for renovations and equipment purchases.-Department lead and SME for the equipment qualification program; authored a new Validation Master Plan; implemented a more efficient GCLP specific program that eliminated reliance on site manufacturing requirements and processes.-Integral member of an engineering project team responsible for the design, construction and fit-out of a new 56,000 sq. ft. facility which included two modern BSL-3 suites compliant with the WHO Global Action Plan (GAP3) for poliovirus work and the CDC Federal Select Agent program.-Primary facility contact for Maintenance and Metrology activities and coordination with lab personnel for PM's and repairs. Review and approve completed vendor service reports, work orders and calibration records.-Manage facility security card access groups and approve new access requests. Perform routine access audits to ensure personnel compliance with training, vaccination and medical monitoring requirements.-Author, review and/or approve quality system documentation (e.g., facility and equipment procedures, specification documents, project plans, facility schematics, P&ID's, qualification protocols / reports, etc.)-Support regulatory audits and internal / external inspections, lead facility tours, and interact directly with auditors; author and provide SME review of change controls; assist with deviation investigations, audit findings and responses, and implement corrective/preventative actions.

Philadelphia, Pa, Us

-Project manager for a managed service solution that provided 45 insourced personnel to support the client’s clinical testing, operations, and administrative platforms. Performed the role of the department's validation manager and directed the daily activities of 3 validation engineers.-Authored and executed equipment qualification protocols, procedures and specification documents for numerous instruments, equipment and utilities in both pharmaceutical research and manufacturing environments at multiple client site locations.

Ny, New York, Us

-Responsible for the daily operations of a 20,000+ square foot health and fitness facility with 2000+ members and 25+ employees. Primary tasks included physical facility operation; financial budgeting and forecasting; membership sales and sales team management; customer relations, service, and retention; front desk, fitness and janitorial staffing; employee development and training; monthly marketing and financial reporting.-As general manager, the club exceeded new membership and personal training sales quotas 21 out of 24 months with three 1st place regional finishes.-Established a clientele of 20+ members for personal training and worked with them to achieve their health and fitness goals through one-on-one fitness prescription and instruction.

Bachelor Of Science, Exercise Science And Sports Studies

Diploma, Network Engineering And Data Communications

Certificate Of Completion, Bsl-3 Laboratory Operations And Maintenance Ii