Khalil Mishref

• Lead, oversee, and execute client project initiatives, plans, or workstreams including ensuring team deliverables are completed in a timely and high-quality fashion.

• Capital Project Management, including Project Controls and Scheduling, Facility Builds, Tech Transfers, Validation Life Cycle, including Commissioning and Qualification, Process Validation, Computer System Validation, etc.

• Develop, execute, and delegate project strategy, initiatives, and vision to effectively lead a small project team.

• Provide hands-on support for both clients and PF Team Members in navigating the life cycle of cutting-edge equipment and manufacturing processes including proactively identifying and escalating roadblocks and utilizing critical thinking skills and knowledge of problem-solving skills to identify creative solutions.

• Supervisory responsibilities for a group of 12 Manufacturing Technicians and over 10 clean room suites.

•SME with various manufacturing equipment including bio-reactors, BSC, ion-exchange chromatography, wave 25/50, Incubators, and filling equipment.

• Manage the manufacturing of Advanced Therapies through Upstream and Downstream Processes such as cell thawing, cell expansion, transfection, harvest and TFF within clean the rooms.

• Execution of batch production for various bulk drug substances ranging from viral vectors to cell and gene therapy products in a cGMP environment.

• Drafting operational protocol(s), internal or external documents including SOPs, BPRs,
deviations and summary reports using electronic drafting systems.

• Collaborate with the Process Development team and MS&T group to transfer new projects into cGMP manufacturing.

• Experienced with PPQ, Water-Runs Engineering and Commercial manufacturing.

• Experienced with FDA, client and internal audits.

•Planed and prepare production, schedule tasks, and assign duties to operators to meet the production schedule, assess production records and meet release timelines to deliver quality product to our customers.

• Generate and revise internal and external documents (SOPs, BRs)

• Lead a team of 6 manufacturing associates to carry out daily production and compliance tasks within the clean room manufacturing environment

• Perform upstream/downstream manufacturing processes for the production of various Therapeutic Products, Master
and Working Cell Banks, Master and
Working Viral Banks, and Final Product Fill.

• Developed expertise and technical leadership in ISO/cGMP compliance and an in-depth understanding of process flow.
  
  • Initiate, Investigate deviations to determine root cause and develop CAPAs to resolve and prevent future occurrence of the deviation.
  
  • Participate in audit readiness and compliance management for FDA/Client and Internal walkthroughs.

• Perform upstream manufacturing processes for the production of Viral Therapeutic Products, Master
and Working Cell Banks, Master and Working Viral Banks, and Final Product Fill.

• Implement a system of planning, scheduling, ordering, kitting, and consumption of materials for all
upstream manufacturing operations with the collaboration of Materials Management and Viral Vector
Manufacturing.

• Utilization of 6S techniques and FIFO to organize production materials storage area to reduce excess
inventory

• Participates in aseptic processing of clinical grade product, including cell culture, purification, formulation and filling activities

• Responsible for investigating and troubleshooting deviations and unexpected events

• Responsible for reviewing, writing and executing production records

• Ensured compliance with industry standards such as ASTM D4169-15, ISTA 1A-1F, ECTC-135.
• Tested upstream and downstream samples of various epoxies, tertiary-amines, intermediates and petrochemical derivatives on various QC lab equipment.
• Performed flashpoint, water content, TOC, GC/LC, IR, Turbidity, dry weight among other tests.
• Train new associates on various QC testing procedures and equipment.
• Instruct operators on progression of out of specification samples to get the batch material back into specification.
• Lab
• Developed non-destructive tests procedures based on industry standards such as ASTM, AWS, ASME.
• Assist in batch record development to align with new CAPAs and industry best practices.