Mark Spinelli Email & Phone Number

St. Louis, Mo, Us

Burlington, Ma, Us

East Brunswick Township, New Jersey, Us

Golden, Colorado, Us

Wichita, Ks, Us

Dublin, Ireland, Ie

Dublin, Ireland, Ie

Dublin, Ireland, Ie

In this role, I have responsibility for facilities, equipment, maintenance, and operations support. I manage the metrology, validation and change control programs and serve as the primary technical resource for engineering, and formulation teams. I also support the stability studies, sterilizer cycle development, quality, regulatory and perform audits at our CRO and CMO facilities.

In this role, I had responsibility for laboratory and stability areas. Responsibilities included engineering, project management, qualifications, metrology, maintenance, and operations support across a large R&D facility. I supported aseptic manufacturing, terminal sterilization and identified and implemented process improvements, quality and compliance at our manufacturing facilities.

In this role, I managed thirty-five direct reports with responsibility for metrology, maintenance and validation in combination with daily operations support of three functional departments including aseptic manufacturing, terminal sterilization, and radiopharmaceutical manufacturing areas.

In this role, I had responsibility for the aseptic, terminally sterilized, and radiopharmaceutical manufacturing areas. Support of the metrology, validation, and project management were my primary focuses.

In this role, I managed and implemented the instrument certification, validation, and revalidation schedules, prepared protocols, developed terminal sterilization cycles and validation requirements for aseptic and terminally sterilized processes.

In this role, I prepared and executed URS, FAT, SAT, CSV, IOQ, and PQ protocols and prepared the data analysis and final reports for regulatory agency review.

In this role, I performed instrument certification and calibration of pharmaceutical equipment instrumentation including stopper processors, depyrogenation ovens, steam sterilizers, distillation systems, HEPA filtration and completed repairs as required.