Experience

Societal™ CDMO

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Scientist III - Product Development

  • 2021 年 4 月 - - 目前

• Scientist II - Product Development

  • 2017 年 5 月 - 2021 年 4 月

  • Client-facing technical lead of the drug product development from R&D through scale up for small molecule oral solid dosage forms for early phase development through phase II clinical trials.• Primary duties include experimental design strategies for formulation/process development and/or optimization, drug product manufacturing (i.e. DOE, technical transfer, scale up, and clinical trials), and evaluation of the formulation and process to identify and determine CQAs, CPPs, and key processing parameters. • Works closely with internal and external cross-functional teams for project planning to ensure timelines are met while maintaining product quality and cGMP compliance. • Authors, reviews, and/or approves cGMP documents throughout the development process including master batch records, manufacturing/engineering/qualification/validation/cleaning verification protocols, reports, raw material specifications, risk assessments, SOPs, change controls, CAPAs, and deviations.• Subject matter expert on manufacturing equipment and on boarding of raw materials.• Key member in establishing a new early phase manufacturing facility; deliverables included evaluating, procuring, and validating manufacturing and analytical equipment; authoring, reviewing, and approving documents to establish the quality management system; and sourcing and procuring raw materials.



Mallinckrodt Pharmaceuticals

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Formulation Scientist

  • 2015 年 6 月 - 2017 年 4 月

  • Led the formulation development of two complex parenteral formulations and utilized QbD principles throughout the formulation development and scale up. • Technical lead in technical transfers of manufacturing processes to a CDMO collaborator and actively participated on a cross-functional team for the drug product development through scale-up.• Responsible for the experimental design and execution of an intrathecal pump compatibility study to assess the chemical and physical stability of the drug product formulation with the material contact surfaces within the intrathecal pump. Authored a series of protocols and reports for the execution of the study.• Actively evaluated and proposed new generic product development opportunities.



CareFusion

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Senior Scientist

  • 2013 年 10 月 - 2015 年 5 月

  While at CareFusion (now a BD company), I was a member of the R&D Sustaining Chemistry team, in which we supported all analytical chemistry activities for the Infection Prevention (topical antiseptics) marketed product lines for all US manufacturing sites.• Actively drove the development and designed the strategy for a new formulation and sterilization process that resulted in an approved patent. • Technical lead for the development and contract manufacturing of a client’s product to ensure compliance with applicable regulatory agencies.• Authored, managed, and performed stability testing to support product development, new regulatory submissions and variations to existing regulatory authorities. Authored extensive and intricate stability reports used to support four Prior Approval Supplement (PAS) submissions to the FDA. • Led the development, remediation, and validation of analytical methods to minimize the lot-to-lot variation of the drug substance. • Organized and managed studies to support regulatory filings in order to relocate internal manufacturing processes to external suppliers.• Gained experience with analytical method development and validation for topical antiseptics in a GMP environment. • Developed management and leadership skills by supervising and training entry-level scientists.



Wolfe Laboratories

• United States
• Chemical Manufacturing

• Postdoctoral Scientist

  • 2011 年 10 月 - 2012 年 2 月

  • Prepared, characterized, and analyzed formulations for concentration, solubility, and stability in pre-formulation and formulation development in a GLP environment. • Utilized DOE to establish the formulation design space of a physically and chemically labile polymer drug conjugate. • Executed experiments, authored reports, and participated in client project updates as the subject matter expert. • Prepared, characterized, and analyzed formulations for concentration, solubility, and stability in pre-formulation and formulation development in a GLP environment. • Utilized DOE to establish the formulation design space of a physically and chemically labile polymer drug conjugate. • Executed experiments, authored reports, and participated in client project updates as the subject matter expert.



Unversity of Kansas

• Hospitals and Health Care
• 1 - 100 Employee

• Graduate Research Assistant

  • 2006 年 8 月 - 2011 年 9 月

  Dissertation Title: Development and Optimization of Polymeric Carriers for Lymphatic Imaging and Drug DeliveryP.I. Dr. M. Laird Forrest•Determined the impact of charge and molecular weight on the kinetics of lymphatic delivery carriers, by varying the size (hyaluronan) and charge (star polymers) of the delivery platforms utilizing in vivo imaging.•Examined the effects of melanoma allografts on the lymphatic drainage of optimized intralymphatic drug carriers utilizing in vivo imaging. •Synthesized, characterized, and determined the anti-cancer efficacy of star polymer-geldanamycin formulations in vitro and in vivo in localized murine breast cancer allografts, murine melanoma allografts, and human melanoma xenografts. •Synthesized, characterized, and determined the stability of a series of prodrug and prodrug-polymer formulations of several labile and poorly soluble chemotherapeutics for the treatment of melanoma. •LC-MS (ESI and APCI) method development for compound verification and pH-stability studies of the synthesized prodrugs, parent drugs, and their intermediates.