Senior Director, Head of CMC

• Oct 2022 - Present

Director

• Aug 2021 - Oct 2022

Associate Director

• May 2020 - Aug 2021

Senior Manager

• Mar 2019 - May 2020

Process Development Scientist I/II

• Jul 2016 - May 2020

Process Development Scientist

• May 2016 - Jul 2016

Sr. Associate Process Development Scientist

• Mar 2011 - May 2016

• 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.• Designed new upstream lab in collaboration with IFDI to support development of next generation process.• Cell culture lead for all commercial GMP investigations.• Initiated development of serum free bioreactor process for next generation manufacture of Imlygic™. Show less

Senior Process Development Scientist

• Mar 2010 - Mar 2011

Process Development Scientist

• Feb 2008 - Mar 2010

• 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. Show less

Development Specialist II

• 2006 - 2008

• 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. Show less

Process Development Assocaite II

• Jun 2004 - Aug 2006

• 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. • Evaluated new methods to analyze host cell DNA in PROSTVAC-VF™ drug substance. • Designed experiments to evaluate novel roller bottle technologies. • Collaborated with QC and Research to evaluate the robustness of the plaque titration assay used to quantitate both PANVAC-VF™ and PROSTVAC-VF™. Show less