Michael Burns Email & Phone Number

Stoneham, MA, US

Cambridge, Massachusetts, United States

Cambridge, Massachusetts, United States

Cambridge, MA

Woburn, MA

Woburn, MA

• Managed the upstream process development group at Amgen Woburn
• Developed and implemented the plan for upstream process characterization of Imlygic™ (formerly OncoVexGM-CSF) to support the BLA filing using the principals of QbD
• Authored the INDa and BLA sections pertaining to process description, validation, and characterization
• Presented process overview and defense strategy during PAI inspections (TGA, FDA, EMA)
• Authored responses to agency questions pertaining to the marketing application
• Created process optimization plan to increase the commercial viability of Imlygic™ resulting in an increase in process robustness and the mitigation of PAI risks.

Woburn, MA

Woburn, MA

• Optimized adherent mammalian cell expansion process for BioVex’s oncolytic gene therapy, OncoVexGM-CSF.
• Conducted studies to reduce cost of goods and streamline upstream disposable OncoVexGM-CSF phase III process.
• Successfully led scale up initiative of OncoVexGM-CSF process, significantly increasing product supply.
• Authored and trained manufacturing technicians on MBR’s and SOP’s as part of OncoVexGM-CSF tech transfer.
• Designed comprehensive studies to support change controls needed to comply with cGMP guidelines.
• Performed risk analysis (FMEA) to design process characterization studies for OncoVexGM-CSF process validation.

Cambridge MA

• Responsible for the scale up of lead candidate conditions/clones into perfusion stir tank bioreactor systems (5L and 10L) for optimization of enzyme replacement manufacturing processes.
• Evaluated 200L disposable perfusion stir tank bioreactor with a goal of producing product for toxicology studies.
• Evaluated multiple cell separation technologies with both aggregate and single cell suspension mammalian cultures for future implementation into the Replagal AF® & Velaglucerase® processes.
• Designed and performed media optimization studies to determine final media formulation for Replagal AF®
• Conducted DOE for process characterization/robustness studies for Replagal AF®.
• Integral part of Elaprase® Investigation Team using JMP to assist in root cause analysis.

Cambridge, MA

• Integral part of development, characterization, and scale-up activities for Therion’s phase II/III gene therapy cancer vaccine products, PANVAC-VF™ and PROSTVAC-VF™.
• Designed robustness studies to characterize and define operational ranges for PANVAC-VF™ using JMP statistical software to support BLA filings and PAI readiness.
• Lead for several major manufacturing investigations
• Responsible for the tech transfer of the upstream portion of PROSTVAC-VF™ process to manufacturing.
• Served as SME for JMP statistical software.
• Prepared technical reports to be included for FDA submission.