Experience

Synlogic

• United States
• Biotechnology Research
• 1 - 100 Employee

• Formulation Scientist II

  • Mar 2022 - Present

• Formulation Scientist

  • Aug 2019 - Feb 2022

• Lead Formulation Associate

  • May 2018 - Jul 2019



Astria Therapeutics, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Associate Scientist, Pharmaceutical Sciences

  • 2016 - Apr 2018

  • Served as preformulation lead on new pre-clinical candidates and as a valuable team member in the early discovery group with the goal of developing new candidate molecules. • Developed amorphous dispersions and lipid based formulations (spray-drying and lyophilization). • Designed and developed IVKS (In-vitro Kinetic Solubility) models to assist in the prescreening of various formulations. • Designed and conducted in-house stability studies of Drug Substance and Drug… Show more • Served as preformulation lead on new pre-clinical candidates and as a valuable team member in the early discovery group with the goal of developing new candidate molecules. • Developed amorphous dispersions and lipid based formulations (spray-drying and lyophilization). • Designed and developed IVKS (In-vitro Kinetic Solubility) models to assist in the prescreening of various formulations. • Designed and conducted in-house stability studies of Drug Substance and Drug Product. • Managed RFP (Request for Proposals) process with external CROs. • Oversaw PK dose development (verifying dose forms and retains) and dosing onsite at external CROs. • Provided analytical and formulation support across functional areas and programs. • Designed and implemented new process by creating a database to tracking retest dates of internal compounds. Show less • Served as preformulation lead on new pre-clinical candidates and as a valuable team member in the early discovery group with the goal of developing new candidate molecules. • Developed amorphous dispersions and lipid based formulations (spray-drying and lyophilization). • Designed and developed IVKS (In-vitro Kinetic Solubility) models to assist in the prescreening of various formulations. • Designed and conducted in-house stability studies of Drug Substance and Drug… Show more • Served as preformulation lead on new pre-clinical candidates and as a valuable team member in the early discovery group with the goal of developing new candidate molecules. • Developed amorphous dispersions and lipid based formulations (spray-drying and lyophilization). • Designed and developed IVKS (In-vitro Kinetic Solubility) models to assist in the prescreening of various formulations. • Designed and conducted in-house stability studies of Drug Substance and Drug Product. • Managed RFP (Request for Proposals) process with external CROs. • Oversaw PK dose development (verifying dose forms and retains) and dosing onsite at external CROs. • Provided analytical and formulation support across functional areas and programs. • Designed and implemented new process by creating a database to tracking retest dates of internal compounds. Show less



Biogen

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Associate Scientist, Assay Services Laboratory

  • 2013 - 2016

  • Method validation of routine and complex assays (small and large molecule) in a GLP laboratory for use in the analysis of preclinical and clinical studies (performance, data processing, and analysis of manual and automated assays (Mulitplex, ELISA, ECL, ADA, and LC/MS/MS)). • Subject Matter Expert (SME) for ~25% of the laboratory’s equipment and assays. • SME for the electronic lab notebook (ELN) application: provided continued guidance for improving efficiency of current workflows and… Show more • Method validation of routine and complex assays (small and large molecule) in a GLP laboratory for use in the analysis of preclinical and clinical studies (performance, data processing, and analysis of manual and automated assays (Mulitplex, ELISA, ECL, ADA, and LC/MS/MS)). • Subject Matter Expert (SME) for ~25% of the laboratory’s equipment and assays. • SME for the electronic lab notebook (ELN) application: provided continued guidance for improving efficiency of current workflows and the development of new workflows. • Created and managed the individual weekly lab schedules of eight personnel and delegated necessary resources to ensure study deadlines were met. • Mentored associate scientists. • Performed preventative maintenance of lab equipment. • Procured and staged all materials required for method validation projects. • Wrote SOPs, validation protocols, and final reports for future FDA filings. • Troubleshot methods and associated lab instrumentation as necessary.

• Associate Scientist III, Assay Services Laboratory

  • 2012 - 2013

  • Performed method validation of routine and complex assays (small and large molecule) for use in the analysis of preclinical and clinical studies in accordance with SOPs and study protocols. • Performed various manual and automated assays (ELISA, ECL, ADA, and LC/MS/MS). • Responsible for performing and documenting the preventative maintenance of lab equipment based within a GLP regulated environment, • Authored SOPs, validation reports/protocols, and other supporting documents for… Show more • Performed method validation of routine and complex assays (small and large molecule) for use in the analysis of preclinical and clinical studies in accordance with SOPs and study protocols. • Performed various manual and automated assays (ELISA, ECL, ADA, and LC/MS/MS). • Responsible for performing and documenting the preventative maintenance of lab equipment based within a GLP regulated environment, • Authored SOPs, validation reports/protocols, and other supporting documents for future FDA filings, • Performed data entry, sample accessioning, and sample tracking via Watson LIMS, • Responsible for troubleshooting methods and associated lab instrumentation as necessary, • Project Lead for the development and implementation of E-Workbook Suite (ELN application) into the laboratory, providing the primary source of documentation practice for validations and studies • Acted as Subject Matter Expert for ~25% of the laboratory’s equipment and assays

• Lab Associate Analyst, Assay Services Laboratory (contract through ICON)

  • 2010 - 2012

  • Performed method validation of routine and complex assays (small and large molecule) for use in the analysis of preclinical and clinical studies in accordance with SOPs and study protocols. • Performed various manual and automated assays (ELISA, ECL, ADA, and LC/MS/MS). • Responsible for performing and documenting the preventative maintenance of lab equipment based within a GLP regulated environment. • Authored SOPs, validation reports/protocols, and other supporting documents for… Show more • Performed method validation of routine and complex assays (small and large molecule) for use in the analysis of preclinical and clinical studies in accordance with SOPs and study protocols. • Performed various manual and automated assays (ELISA, ECL, ADA, and LC/MS/MS). • Responsible for performing and documenting the preventative maintenance of lab equipment based within a GLP regulated environment. • Authored SOPs, validation reports/protocols, and other supporting documents for future FDA filings. • Responsible for troubleshooting methods and associated lab instrumentation as necessary. • Worked with software developers on early phase template development of ELN with the intention of creating a paperless lab environment. • Acted as Subject Matter Expert for ~15% of the laboratory’s equipment and assays.



Roche

• Switzerland
• Biotechnology Research
• 700 & Above Employee

• Validation Scientist, Technical Affairs Department

  • 2007 - 2010

  • Developed complex DOE process validation studies for small benchtop batches to full scale pilot batches in a cGMP setting. Involved in process validation of legacy and newly developed products as well as troubleshooting of in-process and finished commercialized products. • Designed study protocols for process validations which consisted of risk assessment and PQ/PV. • Generated data and documentation in support of new product transfer from R&D through validation to commercial… Show more • Developed complex DOE process validation studies for small benchtop batches to full scale pilot batches in a cGMP setting. Involved in process validation of legacy and newly developed products as well as troubleshooting of in-process and finished commercialized products. • Designed study protocols for process validations which consisted of risk assessment and PQ/PV. • Generated data and documentation in support of new product transfer from R&D through validation to commercial manufacturing (technology transfer); investigated manufacturing process related aspects of products failing to meet specifications; validated changes designed to optimize processes leading to enhanced performance of TDM (Therapeutic Drug Testing) and DAT (Drug of Abuse Testing) assays. • Collaborated with colleagues to analyze and present data at team meetings. • Summarized findings of process validation studies in final reports. Show less • Developed complex DOE process validation studies for small benchtop batches to full scale pilot batches in a cGMP setting. Involved in process validation of legacy and newly developed products as well as troubleshooting of in-process and finished commercialized products. • Designed study protocols for process validations which consisted of risk assessment and PQ/PV. • Generated data and documentation in support of new product transfer from R&D through validation to commercial… Show more • Developed complex DOE process validation studies for small benchtop batches to full scale pilot batches in a cGMP setting. Involved in process validation of legacy and newly developed products as well as troubleshooting of in-process and finished commercialized products. • Designed study protocols for process validations which consisted of risk assessment and PQ/PV. • Generated data and documentation in support of new product transfer from R&D through validation to commercial manufacturing (technology transfer); investigated manufacturing process related aspects of products failing to meet specifications; validated changes designed to optimize processes leading to enhanced performance of TDM (Therapeutic Drug Testing) and DAT (Drug of Abuse Testing) assays. • Collaborated with colleagues to analyze and present data at team meetings. • Summarized findings of process validation studies in final reports. Show less



Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Bioanalytical Chemist, ADME/Preclinical Group

  • 2005 - 2006

  • Developed, validated, and implemented LC/MS/MS methods for high throughput screening involving the quantification and structural identification of lead compounds to determine transport or biotransformation properties in compliance with GLP and OECD guidelines. • Designed, analyzed, and interpreted in vivo/in vitro ADME pharmacology or toxicology studies. • Collaborated with senior scientists to analyze/prepare data for team meetings or research governance committee. • Developed, validated, and implemented LC/MS/MS methods for high throughput screening involving the quantification and structural identification of lead compounds to determine transport or biotransformation properties in compliance with GLP and OECD guidelines. • Designed, analyzed, and interpreted in vivo/in vitro ADME pharmacology or toxicology studies. • Collaborated with senior scientists to analyze/prepare data for team meetings or research governance committee.



Eisai US

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Research Chemist,Drug Disposition

  • 2004 - 2005

  • Contributed to the development and validation of LC/MS/MS methods using Analyst for future FDA submissions. • Performed bioanalytical assays and authored reports for non-clinical and clinical PK studies in a GLP environment. • Contributed to the development and validation of LC/MS/MS methods using Analyst for future FDA submissions. • Performed bioanalytical assays and authored reports for non-clinical and clinical PK studies in a GLP environment.



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Intern

  • 2000 - 2004