Experience

ONK Therapeutics

• Ireland
• Biotechnology Research
• 1 - 100 Employee

• Head Of Manufacturing

  • May 2022 - Present

  Galway, Ireland



Minovia Therapeutics

• Israel
• Biotechnology Research
• 1 - 100 Employee

• Head of Manufacturing and Supply Chain

  • Jul 2020 - Apr 2022

  Cambridge, Massachusetts, United States



Unum Therapeutics

• Director of Technology Operations

  • Sep 2018 - Mar 2020

  • Head of CMC - Responsible for Integrating Analytical & Process Development, Manufacturing, Quality and Regulatory CMC with the business drivers defined by Program Teams and Clinical Operations. Defined requirements, rationale, scope & stakeholders and then driving decisions and tasks to completion. • Managed CMO, CDMO and CTL contracts, scheduling, production, release, storage and stability of plasmids and viral vector drug substances required for production of autologous T cell therapy… Show more • Head of CMC - Responsible for Integrating Analytical & Process Development, Manufacturing, Quality and Regulatory CMC with the business drivers defined by Program Teams and Clinical Operations. Defined requirements, rationale, scope & stakeholders and then driving decisions and tasks to completion. • Managed CMO, CDMO and CTL contracts, scheduling, production, release, storage and stability of plasmids and viral vector drug substances required for production of autologous T cell therapy drug products • Led companies Apheresis task force, to improve and control critical quality attributes of autologous PBMC acquisition • Developed integrated CMC/clinical program timelines for pipeline assets. Routinely presented key decisions to the CEO and Executive Team. • Partnered with Quality and Regulatory teams to update and implement deviation, CAPA, change control and product complaint procedures Show less



OvaScience

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Director Of Operations

  • 2017 - 2018

  Waltham, MAA • Represented technical operations function on executive team, managing corporate strategy and direction • Responsible for overall management of manufacturing, supply & logistics, and QA/QC teams in U.S. and abroad • Partnered with medical affairs group to perform audits, updates and enact needed CAPA at clinical sites • Coordinated with research and PD teams to qualify and implement front-end process improvement steps • Reorganized international warehousing footprint for costs… Show more • Represented technical operations function on executive team, managing corporate strategy and direction • Responsible for overall management of manufacturing, supply & logistics, and QA/QC teams in U.S. and abroad • Partnered with medical affairs group to perform audits, updates and enact needed CAPA at clinical sites • Coordinated with research and PD teams to qualify and implement front-end process improvement steps • Reorganized international warehousing footprint for costs reduction in line with changing corporate strategy • Organized corporate data diligence room to streamline partnering and outsourcing communications • Upgraded EM programs to minimize turnaround time and reduce costs • Revised COGS and S&OP modeling to reflect process and facilities improvements

• Director Cell Processing

  • 2016 - 2017

  Cambridge, Massachusetts, United States • Coordinated with PD, QA, Medical Affairs and commercial team to implement and launch Ovaprime clinical trial • Lead manufacturing team responsible for isolating autologous cellular product for 70 patients involved in phase 1 clinical trials based in Canada and UAE • Streamlined AUGMENT drug product manufacturing process from a 2-day process yielding a fresh product with 4-hour shelf-life to a 1-day process delivering a frozen drug product with a 1-year shelf life • In-housed, and… Show more • Coordinated with PD, QA, Medical Affairs and commercial team to implement and launch Ovaprime clinical trial • Lead manufacturing team responsible for isolating autologous cellular product for 70 patients involved in phase 1 clinical trials based in Canada and UAE • Streamlined AUGMENT drug product manufacturing process from a 2-day process yielding a fresh product with 4-hour shelf-life to a 1-day process delivering a frozen drug product with a 1-year shelf life • In-housed, and optimized antibody conjugation process to increase process control, and reduce costs of critical process raw material • Led product optimization steering committee in a cross-functional review and assessment of all aspects of AUGMENT therapy following first two years of clinical availability • Partnered with commercial/medical affairs teams to develop comprehensive clinical on-boarding package

• Associate Director Cell Processing

  • 2014 - 2016

  Cambridge, MA • Authored, revised and updated manufacturing SOPs, batch records, work instructions and forms • Developed and implemented manufacturing department training and assessment program • Hired, trained, managed international team of 25 production scientists manufacturing autologous cell therapy products • Established production facilities supporting IVF clinics in 6 international regions • Coordinated with R&D, PD, Clinical and Quality teams to refine manufacturing process and establish… Show more • Authored, revised and updated manufacturing SOPs, batch records, work instructions and forms • Developed and implemented manufacturing department training and assessment program • Hired, trained, managed international team of 25 production scientists manufacturing autologous cell therapy products • Established production facilities supporting IVF clinics in 6 international regions • Coordinated with R&D, PD, Clinical and Quality teams to refine manufacturing process and establish in-process controls for AUGMENT and OvaPrime platforms • Collaborated with nursing operations to coordinate tissue procurement, processing and delivery of autologous AUGMENT therapy for more than 300 patients



Agenus

• United States
• Biotechnology Research
• 200 - 300 Employee

• Associate Scientist

  • 2008 - 2013

  Lexington, Massachusetts, United States • Developed and standardized immune assays to monitor and quantify T cell expansion in pre- vs. post vaccination PBMC samples in support of HerpV phase I and II clinical trials • Trained clinical trial sites in blood processing and PBMC isolation • Developed and qualified ELISpot biological potency assay to evaluate autologous T cells responses to HSPPC based Onocophage cancer vaccine candidates • Developed and qualified FACS based T cells activation screening to assay in-vivo… Show more • Developed and standardized immune assays to monitor and quantify T cell expansion in pre- vs. post vaccination PBMC samples in support of HerpV phase I and II clinical trials • Trained clinical trial sites in blood processing and PBMC isolation • Developed and qualified ELISpot biological potency assay to evaluate autologous T cells responses to HSPPC based Onocophage cancer vaccine candidates • Developed and qualified FACS based T cells activation screening to assay in-vivo biological response to Oncophage cancer vaccines • CMO scientific liaison responsible for transitioning clients’ pre-clinical cell therapy procedures to GMP appropriate batch records and subsequent training and supervision of on-site manufacturing staff

• Senior Research Associate

  • 2004 - 2008

  Lexington, Massachusetts, United States • Evaluated effectiveness of HSPPC70 and HSPPC96 vaccine candidates in combination with standard chemotherapeutic combination therapy in murine cancer models • Evaluated/optimized human dendritic cell line propagation protocols for use as autologous APC for ELISpot/CTL assays • Developed and standardized immune cell FACS panels to evaluate fluctuations in cell populations in response to vaccines and chemotherapy dosing in murine models • Developed mycoplasma testing protocol;… Show more • Evaluated effectiveness of HSPPC70 and HSPPC96 vaccine candidates in combination with standard chemotherapeutic combination therapy in murine cancer models • Evaluated/optimized human dendritic cell line propagation protocols for use as autologous APC for ELISpot/CTL assays • Developed and standardized immune cell FACS panels to evaluate fluctuations in cell populations in response to vaccines and chemotherapy dosing in murine models • Developed mycoplasma testing protocol; implemented monthly screening of all active cell lines in tissue culture facility

• Research Associate

  • 2001 - 2004

  Lexington, Massachusetts, United States • Characterized pre-clinical efficiency of lipid contained chemotherapeutic agent in single or combination therapy across a panel of cancer cell lines, murine cancer models and xenograph tumor models • Evaluated QS-21 adjuvant capacity and modulatory effects on B cell, T cell and dendritic cell populations in combination with other clinically relevant adjuvant regimes