Dea Lovy Email & Phone Number

Somerville, Massachusetts, US

Skysona and Zynteglo commercial External Manufacturing and MSAT organization with 10+ reportsMentor and oversee site leads in navigating resolution of complex business, operational, and technical issuesDrive risk mitigation and activities related to increased manufacturing success, speed-to-patient, quality of product, and continuity of supplyOptimization.

Somerville, Massachusetts, US

Cambridge, Massachusetts, US

• Accountable for all aspects of performance (Quality, Supply, and Cost) at contract manufacturers (CMOs) for drug product, including gene therapy drug product, small molecules and mRNA
• Monitor overall CMO network performance, proactively identify risks, and implement actions to reduce the overall risk profile and maintain critical supply
• Establish the strategy and priorities for the cross-functional team
• Lead of RFI and RFP process identification and selection of new CMOs for small molecule and drug product activities
• Attract, retain, and develop a team of direct reports to build out the external manufacturing organization
• Manage Drug Product current and forecasted budget as well as resource planning

Somerville, Massachusetts, US

• Facilitated cross functional transfer of bluebird external manufacturing to new company, including contracts, inventory management, knowledge transfer, supply planning
• Accountable for all aspects of performance (Quality, Supply, and Cost) at bluebird oncology’s designated contract manufacturers (CMOs) including raw material (cell bank, plasmid, small molecules) and drug product CMOs
• Monitor overall CMO network performance, proactively identify risks, and implement actions to reduce the overall risk profile and maintain critical supply

Somerville, Massachusetts, US

Dedicated manufacturing lead for EU and US commercial launch and market expansion activities at Drug Product CMOs

Somerville, Massachusetts, US

• Dedicated manufacturing lead and primary contact for CMO operations management through program lifecycle: tech transfer, clinical operations, PPQ, commercial operations, PAI readiness
• Drove internal operations through team management and quality systems to enable continuous improvement and successful lot release
• Managed and maintained financial and contract structure in support of CMO operations
• Collaborated across cross-functional groups to ensure supply and delivery on program milestones
• Participated in CMC team as vector manufacturing representative
• Authored and reviewed relevant sections for regulatory submission

Somerville, Massachusetts, US

Tokyo, JP, JP

• Experience in upstream and downstream process support and design, including single use and continuous processing. Routine management of and contribution to quality systems and on-floor support as well as tech transfer.
• Upstream SME multi-product single use Ireland Greenfield facility
• Engineering Technical Services site and cross-site support for upstream (roller bottle, bioreactor) and cell banking
• Support of tech transfer projects as area process engineering SME
• Project management including ownership of change controls, CAPAs and deviations
• Revised and drove changes to technical documents including P&IDs, DDS, URS, FS and FRS

Washington, DC, US

• GS-09, Secret Security Clearance
• Managed and tracked product inventory for process control
• Devised and implemented process improvement measures
• Wrote and reviewed technical documents including contracts and SOWs

South San Francisco, California, US

• Interned for Process Sciences and Manufacturing Pilot Plant
• Researched cryopreservation of CHO cells at high density
• Designed and conducted experiments to optimize cryoprotectants
• Final results supported current procedures and materials, and suggested future research areas for cryopreservation
• Explored and improved glass ampoule labeling alternatives to reduce cost and increase label lifetime
• Presented summer research to lead managers meeting, and participated in end of summer intern poster presentation

Baltimore, MD, US

• Researched efficacy of using transmembrane domains to inhibit FGFR-3 mutations
• Performed cell culture, PCR, transfection, cell lysis, and western blot analysis for HEK-293 cell line
• Collected, interpreted, and presented results periodically to team and department

• Assisted researchers in Process Development and Manufacturing division
• Analyzed parameters of capsule sealing machine to optimize performance efficiency
• Results used to update SOPs for capsule sealing
• Sealed, coated, and packaged drug capsules for clinical testing

M.S, Engineering Management; Nano-Biotechnology

Professional Education, Fermentation Technology

B.S., Materials Science And Engineering; Biomaterials