Haytham Khalifa
A dedicated and proactive biopharmaceutical professional with strong experience in Fill Finish operations, facility startup, and cross-functional coordination within GMP-regulated environments.
- Role
- Senior Manufacturing Associate at Moderna
- Location
- Norwood, MA, US
- LinkedIn followers
- 500 followers
About Haytham Khalifa
A dedicated and proactive biopharmaceutical professional with strong experience in Fill Finish operations, facility startup, and cross-functional coordination within GMP-regulated environments. Currently supporting Moderna\'s East building Fill Finish operations, contributing to the successful readiness and launch of commercial manufacturing capabilities.With a hands-on approach, Haytham has played a key role in engineering and buffer runs, facility readiness planning, SOP development, and materials coordination—ensuring seamless integration of systems and operations. Known for a collaborative mindset, Haytham regularly partners with teams across Manufacturing, Engineering, Digital, and EHS to drive project milestones and operational excellence.He is also actively engaged in training initiatives, helping empower employees with tools like Generative AI, tailoring his approach to meet the needs of users from beginners to advanced levels. Haytham’s work directly supports Moderna’s mission to deliver transformative therapies, with a future-focused mindset and an emphasis on continuous improvement.
Experience
Senior Manufacturing Associate
Jan 2022 — Present · Norwood, MA, US
Coordinated facility startup activities, including equipment commissioning, water runs, and material readiness.• Authored and reviewed SOPs and batch records to ensure alignment with cGMP and operational standards.• Improve operations, reduce costs, and increase efficiency.• Follow Good Documentation Practices and Data Integrity requirements.• Establish and follow written procedures.• Qualified trainer for Fill Finish operations.• Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.• MBR and eBR reviews.• Acts as a lead/participates/checks on the work of others in executing Sterile Filtration, Aseptic •• Acts as a lead/participates/checks on the work of others in executing Sterile Filtration, Aseptic • Filling, Visual Inspection, labeling, and Packaging using disposable technologies, automation, • and Manufacturing Execution Systems (MES).• Helped foster a culture of shared accountability and proactive problem-solving across teams.• Authored and reviewed SOPs and batch records to ensure alignment with cGMP and operational standards.Skills and Competencies:• Aseptic Processing Compounding | Sterile Filtration | Fill Finish | Visual Inspection.• Equipment: Optima (SV-125), Vanrx SA-25, Bioquell QUBE, MTI, Steris Autoclave & Parts Washer.• Systems: MES (Syncade), Apprentice, DeltaV, SCADA, SAP, Veeva, LIMS, Aveeva• Digital Manufacturing | SOP & MBR/eBR Development | cGMP | Troubleshooting | Batch Readiness.• Team Leadership | Training & Mentorship | Cross-functional Collaboration.• Microsoft Office (Word, Excel, PowerPoint).
Education
Quincy College
Certifcate in Biotechnolgy & Compliance, Biotechnology
Computer Man College Khartoum , Sudan
Bachelor's degree, Concentration Computer Systems Networking and Telecommunications
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