Experience

Blueprint Medicines

• United States
• Biotechnology Research
• 400 - 500 Employee

• Sr Project Manager, CMC

  • Nov 2022 - Present



Repertoire Immune Medicines

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Manager Quality Control

  • Mar 2022 - Oct 2022

  Cambridge, Massachusetts, United States



2seventy bio

• United States
• Biotechnology
• 200 - 300 Employee

• QC Manager Stability and External Testing

  • Nov 2021 - Feb 2022

  Cambridge, Massachusetts, United States 2seventy bio is a spin-off of bluebird bio encompassing the oncology franchise.



bluebird bio

• United States
• Biotechnology Research
• 300 - 400 Employee

• QC Manager

  • Sep 2021 - Nov 2021

  Cambridge, Massachusetts, United States

• QC, Analytical Product Lead

  • Mar 2020 - Aug 2021

  Cambridge, Massachusetts, United States

• QC, Senior Analyst II Stability

  • May 2019 - Mar 2020

  Cambridge, Massachusetts, United States

• QC, Senior Analyst I Stability

  • Nov 2017 - May 2019

  Cambridge, MA



Genocea Biosciences

• Development Associate III

  • Mar 2017 - Nov 2017

  Cambridge, MA - Stability SME for drug substance and drug product stability programs including in-house studies as well as studies executed at CROs. - Regularly interfaced with CROs and third-party labs to coordinate execution of GMP stability studies. Ensured time points were executed on schedule and performed data review of reports. - Reviewed and approved GMP stability protocols in accordance with ICH guidelines. - Drafted stability results and stability conclusion updates for IND amendments… Show more - Stability SME for drug substance and drug product stability programs including in-house studies as well as studies executed at CROs. - Regularly interfaced with CROs and third-party labs to coordinate execution of GMP stability studies. Ensured time points were executed on schedule and performed data review of reports. - Reviewed and approved GMP stability protocols in accordance with ICH guidelines. - Drafted stability results and stability conclusion updates for IND amendments. - Trended data through linear regression curves and monitored lot-to-lot comparability. - Drafted annual technical reports documenting drug product and drug substance stability results for QA approval. - Authored and reviewed test methods for assays supporting stability studies. - Monitored reference material performance and drafted memos for expiry extensions. - Participated in OOS investigations and drafted deviation reports as appropriate. - Managed drug substance and drug product inventory both in-house and at GMP storage sties. - Regularly presented stability updates at departmental and project team meetings. - Trained and managed associate to execute assays for in-house stability time points and performed final data review after time point completion. - Mentored summer intern and provided training and guidance for work in an analytical laboratory.

• Development Associate II

  • Nov 2015 - Mar 2017

  Cambridge, MA - Stability lead for in-house stability studies for drug substance, drug product, and adjuvant. - Drafted stability protocols, monitored pull schedules, executed assays at designated time points, and performed relevant data analysis and trending. - Regularly performed assays and data analysis for methods including: RP-HPLC, DLS, UV280, SDS-PAGE, Western blot, DSF, residual moisture, osmolality, pH, and appearance. - Provided analytical assay support for in-process, downstream… Show more - Stability lead for in-house stability studies for drug substance, drug product, and adjuvant. - Drafted stability protocols, monitored pull schedules, executed assays at designated time points, and performed relevant data analysis and trending. - Regularly performed assays and data analysis for methods including: RP-HPLC, DLS, UV280, SDS-PAGE, Western blot, DSF, residual moisture, osmolality, pH, and appearance. - Provided analytical assay support for in-process, downstream manufacturing samples. - Assisted with compilation of analytical comparability packages (including assay analysis and documentation) for downstream manufacturing process changes. - Performed reproducibility and robustness testing for HPLC assay qualification. - Implemented inventory management system for formulations on stability. - Maintained documentation of results in support of stability studies.



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Sr Associate

  • Mar 2015 - Oct 2015

  Thousand Oaks, Ca - Preformed all duties outlined below as "Associate" along with the following responsibilities. - Developed study designs for large molecule studies including temperature stability studies, freeze/thaw studies, agitation studies, and other experiments to characterize proteins. - Managed material requirements and prioritized studies when material limited. - Helped pioneer development of formulations for new modalities including BiTE molecules. - Supported study setup and assays for… Show more - Preformed all duties outlined below as "Associate" along with the following responsibilities. - Developed study designs for large molecule studies including temperature stability studies, freeze/thaw studies, agitation studies, and other experiments to characterize proteins. - Managed material requirements and prioritized studies when material limited. - Helped pioneer development of formulations for new modalities including BiTE molecules. - Supported study setup and assays for molecule assessment studies to identify a lead candidate. - Trained new hires on regularly used assays, sample preparation techniques, and data analysis. - Helped develop guidelines and best practices for safety related issues to improve safety culture.

• Associate in Drug Product Formulations Technology

  • Jan 2013 - Mar 2015

  Thousand Oaks, California, United States - Provided support for multiple projects at different stages including cyno monkey studies, first in human formulation development, early stage formulation development, and commercial products. - Performed analytics for both liquid formulations (vials and syringes) and lyophilized formulations. - Assisted with study set-up and formulation preparation including UF/DF, dilutions, concentration, and filtering/filling in a sterile hood environment. - Regularly provided study support and… Show more - Provided support for multiple projects at different stages including cyno monkey studies, first in human formulation development, early stage formulation development, and commercial products. - Performed analytics for both liquid formulations (vials and syringes) and lyophilized formulations. - Assisted with study set-up and formulation preparation including UF/DF, dilutions, concentration, and filtering/filling in a sterile hood environment. - Regularly provided study support and data analysis for assays including: HPLC (SEC, CEX, and Reversed Phase), viscosity, HIAC, MFI, pH, concentration, osmolality, DLS, and visual inspection. - Troubleshot instrument and method issues for different equipment, especially with Agilent HPLC and UHPLC instruments (1100 and 1200 series). - Authored technical reports and drafted material and methods sections for scientific papers. - Prepared and presented data in small group settings as well as department meetings. - Coordinated with project leads to provide study and assay support as needed. - Proficient using common software systems including: Chromeleon 7, Electronic Laboratory Notebooks, and Microsoft Office.

• Research Associate I

  • Mar 2012 - Jan 2013

  Thousand Oaks, Ca - Prepared small molecule formulations for dosing in preclinical studies including toxicology studies. - Assisted with characterization of formulations through small scale screens, solubility measurements, stability tests, and analysis of formulation properties. - Performed RP-HPLC analysis to confirm formulation concentrations and stability. - Prepared reports that summarized formulation preparation details and results of data analysis. - Worked with study coordinators to organize… Show more - Prepared small molecule formulations for dosing in preclinical studies including toxicology studies. - Assisted with characterization of formulations through small scale screens, solubility measurements, stability tests, and analysis of formulation properties. - Performed RP-HPLC analysis to confirm formulation concentrations and stability. - Prepared reports that summarized formulation preparation details and results of data analysis. - Worked with study coordinators to organize formulation preparation timeline and study details. - Maintained electronic laboratory notebooks and updated online databases. - Maintained stock of laboratory supplies and organized shipment of materials as needed.



Optiscan Biomedical

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Laboratory Technician in Research and Development Laboratory

  • Dec 2011 - Mar 2012

  Hayward, CA - Worked in a BSL2 lab with plasma and other potentially infectious materials. - Performed daily calibration and maintenance on various lab equipment. - Planned and designed experiments individually and in small groups to progress R&D projects. - Maintained hard copy documentation of sample results, computer logs of results, lab notebooks, written reports that summarized project results, and entered data in an online database