Robert Reddick Email and Phone Number

The Senior Director is responsible for all GMP engineering and maintenance functions across the clinical and commercial manufacturing network. Responsible for leading Plant / Process Engineering, Maintenance, Metrology, CMMS administration, Commissioning, Qualification and Validation (CQV) programs encompassing GMP equipment, and utilities / HVAC. Accountable for the Reliability and EH&S Programs, and grey utilities engineering for MTC campus.

The Senior Director is responsible for all aspects of the validation specifically the development and implementation of strategy, policy and procedure across both the oligomer (RNA) and gene therapy platforms. Responsible for the development and implementation of phase appropriate quality and validation programs. Oversees the technical transfer, equipment / facility / utility commissioning and qualification, computer systems validation, process and cleaning validations at both domestic and international CDMOs for drug substance, drug product and finished goods manufacturer. Provides guidance on application of GMP principles and standards for US and international agencies.

The Director of Engineering Services is responsible for the leadership, direction, and development of company personnel through all technical aspects of the project lifecycle. Oversees the overall timelines and quality of support provide both individually and by others reporting to the Director. subject matter expert for project management, scheduling, and reporting.

The Director of Site Engineering Services is responsible for all engineering, process automation and validation activities at the Alexion Rhode Island Manufacturing Facility (ARIMF) for commercial and clinical products. The responsibility includes process engineering, facilities and utilities engineering, process automation, equipment/facility/utility validation, cleaning validation and process validation. This position will be the owner of process and support systems lifecycle, in addition to equipment and general engineering, automation, and validation procedures. The position will manage site engineering services to support of 24 × 7 manufacturing operations; fostering effective cross-functional working relationships with Manufacturing, Technical Services, Facilities, Logistics, Quality Assurance and Quality Control groups which support day-to-day operations; and providing support for Regulatory inspections/submissions related to commercial and clinical products manufactured at this facility. This Director is expected to perform all duties in compliance with Good Manufacturing Practices (cGMPs) and in accordance with Alexion procedures; to lead the team is in the initiation and completion of deviations, CAPAs and Change Controls and will build and maintain rapport with customers and stakeholders ensuring GMP compliance and facilitating maintaining the manufacturing schedule.

The Director of Engineering & Automation is responsible for all engineering and process automation activities at the Alexion Rhode Island Manufacturing Facility (ARIMF) for commercial and clinical products. The responsibility includes process engineering, facilities and utilities engineering, and process automation. This position will be the owner of process and support systems design, in addition to equipment and general engineering and automation procedures. The position will manage engineering and process automation support of 24 × 7 manufacturing operations; fostering effective cross-functional working relationships with Manufacturing, Technical Services, Facilities, Validation, Logistics, Quality Assurance and Quality Control groups which support day-to-day operations; and providing support for Regulatory inspections/submissions related to commercial and clinical products manufactured at this facility. This Director is expected to perform all duties in compliance with Good Manufacturing Practices (cGMPs) and in accordance with Alexion procedures; to lead the team is in the initiation and completion of deviations, CAPAs and Change Controls and will build and maintain rapport with customers and stakeholders ensuring GMP compliance and facilitating maintaining the manufacturing schedule.

The Director of Validation leads a Validation group responsible for the qualification of process and ancillary equipment (DQ,/IQ/OQ/PQ), facility qualification (controlled environments), automated process control system qualification, critical utility qualification, cleaning validation, computer validation, and/or process validation required to support compliant cGMP commercial and clinical manufacture in the facility. The position requires establishing effective working teams and processes and fostering cross-functional working relationships with quality, manufacturing and technical services functions in support of day-to-day operations, as well as providing support for regulatory inspections and submissions related to commercial and/or clinical products manufactured at the ARIMF facility.