Experience

Pacira BioSciences, Inc.

• United States
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Director Analytical Development, Cell and Gene Therapies

  • Nov 2022 - Present



Flexion Therapeutics

• United States
• Biotechnology Research
• 1 - 100 Employee

• Associate Director

  • May 2021 - Oct 2022

  ● Technical transfer and integration of Flexion CGT program to Pacira as part of acquisition. ● Development and execution of analytical strategy for FX201 HDAd gene therapy program. ● Management of external and internal analytical assay development including; novel product specific potency assays, critical optimization of early phase assays, and phase appropriate development of compendial assays. ● Oversight and coordination of release testing and collaboration with… Show more ● Technical transfer and integration of Flexion CGT program to Pacira as part of acquisition. ● Development and execution of analytical strategy for FX201 HDAd gene therapy program. ● Management of external and internal analytical assay development including; novel product specific potency assays, critical optimization of early phase assays, and phase appropriate development of compendial assays. ● Oversight and coordination of release testing and collaboration with process and quality teams to ensure disposition of manufactured DS and DP. ●Lead analytical and/or process investigations and SME partner for contract organization audits. ● Lead, grow, and mentor analytical development scientists. Show less ● Technical transfer and integration of Flexion CGT program to Pacira as part of acquisition. ● Development and execution of analytical strategy for FX201 HDAd gene therapy program. ● Management of external and internal analytical assay development including; novel product specific potency assays, critical optimization of early phase assays, and phase appropriate development of compendial assays. ● Oversight and coordination of release testing and collaboration with… Show more ● Technical transfer and integration of Flexion CGT program to Pacira as part of acquisition. ● Development and execution of analytical strategy for FX201 HDAd gene therapy program. ● Management of external and internal analytical assay development including; novel product specific potency assays, critical optimization of early phase assays, and phase appropriate development of compendial assays. ● Oversight and coordination of release testing and collaboration with process and quality teams to ensure disposition of manufactured DS and DP. ●Lead analytical and/or process investigations and SME partner for contract organization audits. ● Lead, grow, and mentor analytical development scientists. Show less



Voyager Therapeutics, Inc.

• United States
• Biotechnology Research
• 100 - 200 Employee

• Sr Scientist II

  • Nov 2020 - May 2021

  ● Management of the analytical development and process analytics team. Assays utilized various chromatography, proteomic, qPCR/ddPCR, and biophysical applications. ● Research to development (R2D) planning and oversight for analytical and process development transitions. ● Analytical representative on early and clinical stage CMC teams. ● Management of the analytical development and process analytics team. Assays utilized various chromatography, proteomic, qPCR/ddPCR, and biophysical applications. ● Research to development (R2D) planning and oversight for analytical and process development transitions. ● Analytical representative on early and clinical stage CMC teams.



bluebird bio

• United States
• Biotechnology Research
• 300 - 400 Employee

• Scientist II -Drug Product Analytical Development

  • Mar 2018 - Nov 2020

  ● Management of the gene therapy drug product analytical development team. Responsibilities include development, qualification, and life cycle management of drug product in-process, characterization, and release assays. Assays utilized various chromatography platforms, mass spectrometry, enzymatic, proteomic, and biophysical applications. ● Analytical development representative for bluebird bio portfolio for all clinical and commercial investigations. ● Management of analytics and process… Show more ● Management of the gene therapy drug product analytical development team. Responsibilities include development, qualification, and life cycle management of drug product in-process, characterization, and release assays. Assays utilized various chromatography platforms, mass spectrometry, enzymatic, proteomic, and biophysical applications. ● Analytical development representative for bluebird bio portfolio for all clinical and commercial investigations. ● Management of analytics and process development for small molecule transduction enhancer manufacturing and regulatory documentation. ● Analytics representative for severe genetic disease candidate(s) CMC team. Responsibilities include contribution to planning and execution of early stage development and communications with agencies. ● Developed bluebird bio cross platform potency assay strategy for multiple regulatory agencies. ● Participate and aid in regulatory filings and responses for both the EMA and FDA. ● Direct oversight of five individual scientists, matrix leadership of cross functional teams, and extensive CxO management.

• Scientist - Cellular Analytics

  • May 2017 - Mar 2018

  Team lead for cellular analytics assay development and CRO collaboration for gene and cellular therapy applications.



Alexion Pharmaceuticals, Inc.

• United States
• Biotechnology Research
• 700 & Above Employee

• Scientist

  • May 2015 - Apr 2017

  ● Designed and evaluated methodologies in support of the development of protein therapeutics. ● Collaborated with regulatory teams to address PMC’s and communicate responses and data. ● Developed and compared assays to measure and evaluate kinetics and other key parameters required by the regulatory agencies. ● Designed methodologies to detect and quantify HCP’s for ongoing protein production efforts. ● Cultivated technical experience with automated liquid handling systems and cell… Show more ● Designed and evaluated methodologies in support of the development of protein therapeutics. ● Collaborated with regulatory teams to address PMC’s and communicate responses and data. ● Developed and compared assays to measure and evaluate kinetics and other key parameters required by the regulatory agencies. ● Designed methodologies to detect and quantify HCP’s for ongoing protein production efforts. ● Cultivated technical experience with automated liquid handling systems and cell culture of primary and immortalized cell lines. Show less ● Designed and evaluated methodologies in support of the development of protein therapeutics. ● Collaborated with regulatory teams to address PMC’s and communicate responses and data. ● Developed and compared assays to measure and evaluate kinetics and other key parameters required by the regulatory agencies. ● Designed methodologies to detect and quantify HCP’s for ongoing protein production efforts. ● Cultivated technical experience with automated liquid handling systems and cell… Show more ● Designed and evaluated methodologies in support of the development of protein therapeutics. ● Collaborated with regulatory teams to address PMC’s and communicate responses and data. ● Developed and compared assays to measure and evaluate kinetics and other key parameters required by the regulatory agencies. ● Designed methodologies to detect and quantify HCP’s for ongoing protein production efforts. ● Cultivated technical experience with automated liquid handling systems and cell culture of primary and immortalized cell lines. Show less



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Scientist

  • May 2006 - Apr 2015

  As part of chemical genetics team, developed methods for small molecule affinity enrichment techniques utilizing a customizable matrix coupled to investigative compounds to enrich for unknown target proteins within custom lysates for detection by mass spectrometry. As part of chemical genetics team, developed methods for small molecule affinity enrichment techniques utilizing a customizable matrix coupled to investigative compounds to enrich for unknown target proteins within custom lysates for detection by mass spectrometry.



NitroMed

• Scientific Associate

  • 2002 - 2006