Experience

Kymanox

• United States
• Biotechnology
• 100 - 200 Employee

• Director, CMC Program Management

  • Jun 2021 - Present



Nicox

• France
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Director of CMC and Pharmaceutical Development

  • Oct 2020 - Jun 2021

• Director of CMC and Pharmaceutical Development

  • Oct 2018 - Oct 2020

  Led the technology transfer, analytical method development and transfer, and Phase 2 clinical trial material manufacturing campaign for a sterile ophthalmic suspension drug product (NCX 4251), intended to treat blepharitis and dry eye.Assisted with the development of a sterile ophthalmic solution drug product (NCX 470) intended to treat ocular hypertension and open-angle glaucoma, from Phase 2 through its current stage in Phase 3 clinical trials.Contributed to CMC modules of multiple FDA regulatory filings in support of NCX 4251 and NCX 470 development. Supported international licensing collaborations with external partners for those and other drug products in the Nicox pipeline by facilitating the transfer of CMC-related product knowledge and information.



Kymanox

• United States
• Biotechnology
• 100 - 200 Employee

• Manager of Quality Engineering

  • Jan 2018 - Oct 2018

  Managed the Quality Engineering Group, focused on device development, process improvement, and biopharmaceutical manufacturing tech transfer projects.Provided technical oversight, project management, and subject matter expertise for multiple medical device and combination product development projects, including both commercial and clinical product applications. Managed the development of a clinical dosing aid combination product, to be used for pediatric administration of a commercially-available drug product. This involved creation of all design controls, oversight of the pilot build manufacturing and design verification / validation testing, and transfer of the design to a third party responsible for clinical preparation of the final combination product.

• Senior Engineer

  • Jun 2017 - Dec 2017

  Provided technical project management support for medical device and combination product development, including both commercial and clinical product applications. Authored technical development protocols and reports for a Process Performance Qualification (PPQ) campaign for a monoclonal antibody biologic product in a sterile solution presentation.Performed Quality Management System audits and Design History File gap assessments for multiple clients developing medical devices and combination products, against FDA Part 820 regulations, ISO 13485, and ISO 14971 standards.



Envisia Therapeutics

• Biotechnology Research
• 1 - 100 Employee

• Senior Process Development Engineer

  • Feb 2016 - Jun 2017

  Led in developing manufacturing plans for drug products in development, from pre-clinical through Phase 3 clinical studies. Assisted in technology transfer of a novel manufacturing process to an aseptic processing suite in support of clinical trial material production. Authored SOPs, IOQ protocols, BPRs, and drug product specifications for pharmaceutical development and manufacturing activities. Led in developing manufacturing plans for drug products in development, from pre-clinical through Phase 3 clinical studies. Assisted in technology transfer of a novel manufacturing process to an aseptic processing suite in support of clinical trial material production. Authored SOPs, IOQ protocols, BPRs, and drug product specifications for pharmaceutical development and manufacturing activities.



Kymanox

• United States
• Biotechnology
• 100 - 200 Employee

• Process Engineer

  • Jun 2014 - Jan 2016

  Applied Kymanox’s unique “Ideal Knowledge Transfer” methodology to help clients realize efficient and effective results Performed process characterization and supported manufacturing operations for the production of an ophthalmic implant drug product. Also evaluated and selected primary and secondary packaging for the drug product based on known manufacturing and clinical constraints Authored commissioning documents, SOP's, and IOQ Protocols and executed qualification activities to support validation of custom-built nano-particle fabrication equipment. Developed guidelines for the scale-up of a 3.5 liter laboratory solution preparation process to a 20 liter manufacturing-scale process, while integrating single-use, disposable components to reduce cost and improve throughput. Created protocols which established resin lifetimes for a manufacturing-scale antibody purification process, and verified those lifetimes through continued column monitoring during production operations.



Biogen

• United States
• Biotechnology Research
• 700 & Above Employee

• Technical Development Co-op

  • May 2013 - May 2014

  Developed a next-generation, non-Protein A process for antibody purification, which uses PEG/zinc chloride precipitation as a primary decoupling capture step followed by a three-column purification approach Worked extensively at lab scale with multiple modes of chromatography and gained a strong knowledge of the theory behind protein separation. Became proficient with AKTA chromatography systems and the Unicorn software package Designed an assay for the detection and quantification of residual PEG in final product samples, which utilized reversed-phase HPLC coupled with Corona charged aerosol detection



Advanced Liquid Logic

• Research Triangle Park, North Carolina

• Cartridge Engineering Intern

  • Oct 2012 - May 2013

  Contributed to various projects involving the development of single-use assay cartridges based on Advanced Liquid Logic’s proprietary electrowetting technology Responsibilities include supporting new product development by designing and conducting experiments to investigate validity of cartridge designs and effectiveness of implemented features Contributed to various projects involving the development of single-use assay cartridges based on Advanced Liquid Logic’s proprietary electrowetting technology Responsibilities include supporting new product development by designing and conducting experiments to investigate validity of cartridge designs and effectiveness of implemented features



Triangle Biomedical Sciences

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Engineering/Manufacturing Intern

  • Jul 2012 - Aug 2012

  Summer internship at a company that designs, manufactures, distributes, and services histology lab equipment and associated consumables. Assisted in the design, prototyping, and quality testing of new products, including the SHUR/Mark II slide labeler Documented and improved multiple manufacturing and engineering processes according to ISO 9001 standards and cGMPs by conducting interviews with members of various departments within the company. Created manufacturing work instructions, which consolidated the process for manufacturing products such as the Advanced Tissue Processor. Conducted quality control on tissue biopsy cassettes and other products manufactured within the company and by third-party manufacturers.



Duke University

• United States
• Higher Education
• 700 & Above Employee

• Pratt Undergraduate Research Fellow

  • Jan 2011 - Jun 2012

  Independently designed, executed, and analyzed the results of graduate-level research projects in the field of biomaterials and drug delivery mechanisms Investigated change in secondary structure upon microglassification, a novel method for dehydrating proteins, of lysozyme as well as three different forms of hemoglobin using Fourier Transform Infrared Spectroscopy (FTIR) Explored the effects of adding surfactants to the microglassification emulsion on bead size, bead surface properties, secondary structure, recovery potential, and specific enzyme activity upon recovery



DARSI Lab, Duke Medical Center

• Durham, North Carolina

• Work-Study Student

  • May 2010 - Dec 2010

  Assisted with research and clinical studies in the Duke Advanced Research in SDOCT Imaging Laboratory Programmed software in MATLAB for image analysis, specifically to calculate volume of retinal layers in infants diagnosed with retinopathy of prematurity (ROP) Managed data systems and conducted analysis pertaining to studies in the areas of ROP and macular degeneration Assisted with research and clinical studies in the Duke Advanced Research in SDOCT Imaging Laboratory Programmed software in MATLAB for image analysis, specifically to calculate volume of retinal layers in infants diagnosed with retinopathy of prematurity (ROP) Managed data systems and conducted analysis pertaining to studies in the areas of ROP and macular degeneration



HHMI, Duke University, You lab

• Durham, North Carolina

• Howard Hughes Fellow

  • May 2009 - Aug 2009

  Research involved significant hands-on work with mammalian cell cultures, as well mathematical modeling methods and statistical simulations. Developed stochastic simulations in MATLAB of the RB-E2F pathway, a genetic pathway central to the proliferation of healthy cells and the death of oncogenic cells; presented results to a panel of experts, mentors, and peers. Modeled intrinsic and extrinsic variability in cells when mapping protein expression levels; collaborated with wet lab personnel to perturb certain parameters within the pathway in actual mammalian cell cultures.