Robert Lowery Email & Phone Number

Basel, Baselstadt, CH

Basel, Baselstadt, CH

Supported Manufacturing Downstream, Drug Product and Buffers as investigation lead and change record owner.

Basel, Baselstadt, CH

Long Beach, CA, US

• Consultant for Pfizer, INC. located in McPherson, KS.
• Project lead to facilitate the addition of three (3) new autoclaves into the equipment preparatory areas of the Kansas facility.
• Managed +15 people from different contract organizations to facilitate the addition of new autoclaves.
• Maintained a project budget of +2.50MM throughout the duration of the project and coordinated changes requests as necessary.
• Served as a technical expert on the sterilization of porous and non-porous commodities.
• Performed cycle optimization of legacy systems to ensure that they consistently met the equilibration requirements for the load.

Long Beach, CA, US

• Consultant at United Therpeutics in RTP, NC
• Performed cycle development for the autoclave installation at the site.
• Wrote, Executed and pushed approval of the IOQ/PQ protocols for the autoclave, temperature control units (ie. refrigerators, freezers and incubators), and filter integrity testers for the site.

New York, New York, US

• Managed the supplier quality audit program, the supplier change notification program, the approved supplier list and special projects within supplier quality/incoming quality
• Performed supplier quality audits, risk categorization assessments, risk mitigations, supplier quality audit report peer reviews, supplier change notifications, change requests, exception reports, SCARs, corrective and.
• Provided direct quality oversight to purchasing/procurement, receiving and manufacturing for new and existing supplier qualifications and defects
• Maintained department SOPs, test masters, specifications and forms to ensure that they were compliant with regulatory guidance and updated applicable documents as necessary using the change control system
• Supported site regulatory audits from a technical background for supplier quality/incoming quality

Lake Forest, IL, US

• Lead a cross-functional team that established a course of action for the remediation efforts associated with Vapor-Phase Hydrogen Peroxide (VHP) and Aseptic Process Simulation (APS) programs
• Generated the site project validation plan for VHP which included a technical assessment of each system, a comprehensive summation of the validation history, and an overall assessment of the compliance of each system
• Executed all stages of the validation life-cycle including installational qualification, operational qualification, performance qualification and requalification for various sterilization principles and equipment
• Provided technical support and training opportunities while managing the use and maintenance of the Kaye validators in conjunction with commissioning and qualification validation activities
• Maintained protocols, SOPs, specifications and validation plans to ensure that they were compliant with regulatory guidance
• Updated applicable documents using the change control system, investigated validation deviations, and managed corrective actions

Basel, Baselstadt, CH

• Supported the commissioning and qualification of the Bulk Processing Facility and Viral Pilot Plant addition
• Startup protocol development for IQ/OQ/PQ as it applied to process equipment, TCUs and laboratory equipment
• Generated summary reports and validation plan reports to summarize completed validation studies
• Direct involvement with quality assurance to address protocol deviations and to determine a path forward for situations that would involve additional testing
• Worked one-on-one with quality assurance to approve engineering protocols, deviations, and corrective actions
• Coordinated vendor assisted installation and operational qualification of laboratory bench top equipment

Basel, Baselstadt, CH

• Supported Compliance Quality Assurance with the implementation of the Novartis Quality Systems
• Organized the Novartis Quality Manual into sections based on need and prioritized their implementation across multiple departments in an organized and efficient manner
• Monitored the implementation of the Quality Manual standards into local site SOPs and procedures.
• Supported SMEs during implementation to drive GAPs and bring Quality Control systems into place for site readiness, inspection and production
• Facilitated meetings with SMEs to determine potential GAPs between Global Quality Standards and SOPs
• Created a process of identifying the GAPs for multiple departments and facilitated their efficient mitigation

Bagsværd, DK

• Executed membrane filtration on samples from in-process, water and ancillary bioburden testing
• Performed water endotoxin analytical testing (colorimetric determination)
• Incubated, read and interpreted environmental monitoring plates using SDA, TSA, EMB and R2A selective media
• Assisted chemistry department with the creation of mobile phases for analytical testing

Brentford, Middlesex, GB

• Performed good laboratory practices to promote safety and efficiency for the in vivo/in vitro biochemical research laboratories
• Created general stock solutions and mobile phases for the analytical laboratories
• Ordered supplies for the lab and kept inventory of the supplies

Bs, Microbiology

As, Industrial Pharmaceutical Technology