Lorna Mason

• Validated complex systems by following rigorous testing protocols, confirming their functionality and reliability before deployment. Was involved in B16A Facility Project as Validation Lead which covered the following

Facility Qualification- Protocol Generation, Testing and inspections that were required, reviewing Non-Conformances prior to release.

BMS- Testing and inspections that were required, reviewing Non-Conformances prior to release.

Nitrogen (PSA) and Utilities- Protocol Generation, Testing and inspections that were required, reviewing Non-Conformances prior to release.

• Communicated effectively with stakeholders regarding the progress of validation activities, fostering a collaborative work environment.
• Participated in audits conducted by regulatory agencies, providing necessary documentation and addressing any concerns promptly.
• Assisted in the development of standard operating procedures for the Validation department, promoting consistency across all projects.
• Managed multiple concurrent projects, ensuring timely completion of validation tasks and meeting project deadlines.
• Collaborated closely with other departments to ensure seamless integration of validated systems into the larger operational framework.

• Involved in the PPT and Small Molecule Operations in B20 (Almac House) under the following processing techniques.

Small Molecule batch Manufacturing

Distillations

Filtrations

Cleave Process PPT

Synthesis Process PPT

Purification Process PPT

Final Isolation

• Enhanced product quality through regular equipment maintenance and troubleshooting of process issues.
• Contributed to the development of validation protocols for new equipment installations, ensuring proper functionality before full-scale production began.
• Assisted engineering team with process development, leading to the successful launch of new products in a timely manner.
• Attended training seminars and met with vendors to understand new equipment and train other employees.
• Managed multiple projects simultaneously, prioritizing tasks and allocating resources effectively to ensure timely completion.

• Involved with Small Molecule Production Plant which entailed the following processing techniques

Distillations

Phase Separation

Charging/Discharging of Chemicals/Solvents

Filtration

Cleaning of Equipment

Monitoring of Processing using DCS/Delta V

Final Isolation of API's (Active Pharmaceutical Ingredients)

• Involved with investigations for technical issues from equipment or batch processing promptly through effective root cause analysis and corrective action implementation, minimizing downtime and maintaining production schedules.
• Contributed to the development of validation protocols for new equipment installations, ensuring proper functionality before full-scale production began.
• Complied with safety rules and standards to maximize efficiencies while reducing accidents.
• Managed inventory of spare parts and consumables required for daily operations, reducing stockouts and ensuring smooth workflow transitions between shifts.

• Established clear priorities and production quality standards, under GMP and HACCP Quality Systems
• Resolved issues quickly to maintain productivity goals.
• Managed team of 9 production associates, overseeing productive production processes and meeting all deadlines.
• Managed internal operational standards and productivity targets.
• Evaluated existing production processes and identified areas for improvement.
• Implemented safety protocols and conducted regular audits, achieving a reduction in workplace accidents and incidents.
• Coordinated with Stores department to maintain smooth and efficient release and dispatch of products.
• Maintained accurate documentation of production data, enabling informed decision-making for process improvements.
• Streamlined communication between departments, fostering a collaborative work environment for efficient problem solving.
• Managed staff hiring, training and supervision.

• Was involved as a Process Technician in the following areas

Drug Substance processing techniques

Cell Culture

Harvesting

Cleaning of Equipment

Using DCS for monitoring of Equipment

• Provided technical support to all projects and provided research for all developmental teams.
• Reduced downtime for maintenance by performing regular equipment inspections and preventative measures.
• Provided hands-on assistance during emergency situations such as equipment malfunctions or shutdowns while maintaining composure under pressure.
• Assisted in the development of training materials and resources to enhance the onboarding experience for new process technicians.