Michael Mohamed Email & Phone Number

Columbus, Ohio, United States

Responsible for the facilitation and supervision of all commercial operations, including unit dose cups, syringes, robotic and non-robotic bottling, overwrap and flagging services.

United States

• As a key technical resource, I represented QC Microbiology during internal and external audits. In addition to the above, I improved and developed processes by restructuring SOPs, methods, and documents, introducing.
• Spearheaded the development of the Environmental Monitoring Performance Qualification (EMPQ) protocol and trained approximately 50 personnel.
• Successfully completed EMPQ for 67 new cGMP cleanrooms to meet major company KPIs and facilitate cGMP activities.
• Supported the development and validation of a Veeva-based LIMS to enhance data management and laboratory efficiency.
• Directed the implementation of cost improvement plans, optimizing resources and reducing expenses related to microbial testing and environmental sampling.
• Created personnel monitoring (PM) and gown qualification processes in compliance with ISO and Annex 1, and initiated CAPAs for qualification.

Hilliard, Ohio & New Albany, OH

• During my time here, I managed two distinct facilities equipped with specialized EM equipment used within high-speed RABS, isolator, and lyophilization lines for solid and liquid dose products. Further, I played a.
• Earned a Six Sigma Green Belt by spearheading a project that reduced the testing phase duration by 50%, expediting product release processes and generating substantial savings.
• Played a pivotal role in the design, build, validation, and performance optimization of the Laboratory Information Management System (LIMS).
• Led the rollout of Labware-based LIMS, enhancing data integrity and laboratory efficiency across two facilities.
• Identified root causes of excessive particulate matter during major construction and created CAPAs, implementing multiple process improvements and adding air scrubbers in dedicated locations.
• Conducted EMPQ activities for 12 new cleanrooms, expanding the company’s manufacturing capacity.

Hilliard, Ohio

• Here, I directed and mentored 10 Environmental Monitoring Technicians (EMTs) in routine and comprehensive sampling protocols, including viable active, passive, and contact environmental sampling, non-viable particulate.
• Enhanced the… Show more Here, I directed and mentored 10 Environmental Monitoring Technicians (EMTs) in routine and comprehensive sampling protocols, including viable active, passive, and contact environmental.
• Enhanced the gowning re-qualification process, reducing the time required for personnel certification for clean and sterile area entry.
• Developed and delivered training materials for FDA audits, ensuring all personnel were well- prepared and compliant with regulatory expectations.
• Completed EMPQ and PQ activities for three high-speed manufacturing lines, water ports, and gases, followed by Media Fills to achieve company KPIs.
• Performed environmental excursion investigations and deviations, reducing the number of open days by 30%.

Hilliard, Ohio

• While working here, I mentored, trained, and provided feedback to QA associates, ensuring effective direction for all activities. Other duties of mine were, communicating with essential information to ensure team.
• Identified… Show more While working here, I mentored, trained, and provided feedback to QA associates, ensuring effective direction for all activities. Other duties of mine were, communicating with essential.
• Identified documentation and process related gaps in overall SOPs, QC and GMP activities.
• Provided audit oversight and completion of appropriate documentation for shipment of product to client/customer.
• Generated controlled documents and performed audits of routine documentation, logbooks, labels, batch records (BRs) and laboratory areas.
• Reviewed and approved room release clearances to ensure documentation was in accordance with cGMP and GDP.

Oregon, Ohio

• As a project manager, I planned, executed, and completed projects within budget and schedule constraints. By leading team members and defining goals through communication with key stakeholders, I ensured that project.
• Allocated personnel, equipment, and support resources based on project needs and extenuating circumstances.
• Appointed and… Show more As a project manager, I planned, executed, and completed projects within budget and schedule constraints. By leading team members and defining goals through communication with key stakeholders.
• Appointed and scheduled employees work load and contractors too efficiently meet work deadlines.
• Directed and coordinated all resources to ensure property met owner objectives.
• Effectively communicated with owners, contractors and court system to meet all issues.

B.S. Degree, Biology/Biological Sciences, General

Received B.S. Degree

As Degree, Environmental Science

Received Associates Degree

Executive Mba, Project Management