David Diguiseppi, Phd

David Diguiseppi, Phd Email and Phone Number

Principal Scientist- Analytical Development and Quality Control @ BioAnalysis, LLC
David Diguiseppi, Phd's Location
Philadelphia, Pennsylvania, United States, United States
About David Diguiseppi, Phd

Driven Principal Scientist and Biophysical Chemist with extensive expertise in gene therapy, Analytical Development, Quality Control, and startups. Constantly exceeding industry experience expectations in leading biotechnology companies focused on rare diseases. Demonstrated expertise in analytical chromatography and biophysical methods, playing a pivotal role in their design and validation as an integral part of the Analytical and Technology Development division. I've been instrumental in establishing and managing Analytical Development and Quality Control labs, fostering collaboration with CDMOs and CROs, serving as the primary audit contact, and readily step into the role of Interim Associate Director as needed. Additionally have developed and optimized analytical and biophysical characterization methods based on biological/biochemical techniques to support AAV gene therapy vectors. Strong professional scientist at a gene therapy company with a Doctorate (PhD) focused in Biophysical Chemistry and Biospectroscopy from Drexel University.I have a demonstrated history of working in experimental spectroscopy and biophysical chemistry specialized in Size Exclusion Chromatography (SEC-MALS), Field-Flow-Fractionation (FFF-MALS), DLS, RP-HPLC, Peptide Mapping and Capsid ID, Ultra-Violet Electronic Circular Dichroism (UVCD or ECD), Vibrational Circular Dichroism (VCD), Infrared Spectroscopy, Fluorescence Spectroscopy, Raman Spectroscopy, NMR Spectroscopy. Skilled in CE-SDS, SDS-PAGE, GC/MS, Rheology, Atomic Force Microscopy (AFM), Scanning and Transmission Electron Microscopy (SEM and TEM), various light scattering techniques, various fitting programs, etc

David Diguiseppi, Phd's Current Company Details
BioAnalysis, LLC

Bioanalysis, Llc

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Principal Scientist- Analytical Development and Quality Control
David Diguiseppi, Phd Work Experience Details
  • Bioanalysis, Llc
    Principal Scientist
    Bioanalysis, Llc May 2024 - Present
  • Passage Bio
    Senior Scientist Ii/Principal Scientist
    Passage Bio Jan 2023 - Jul 2023
    Philadelphia, Pennsylvania, Us
    • Served as Interim Associate Director multiple times throughout tenure.• Managed a team of three varying level scientists through method development, OOS investigations, and data review for both AD and QC standards.• Accountable for method development, method qualification, and tech transfer of AAV drug substance, drug product, and stability testing for phase 1/2 IND submissions.• Facilitated the opening of the company’s inaugural Analytical Development and Quality Control lab facility, responsible for equipment procurement, vendor contracts, and method planning.• Developed and validated physical chemistry analytical techniques for AAV gene therapy vectors, ensuring GMP compliance and alignment with regulatory guidelines including international affairs.• Established as the team's subject matter expert for SEC-MALS, RP-HPLC, DLS, AUC, Peptide Mapping (BioAccord LC-MS), Capsid ID, and Pluronic assays (UPLC-CAD).• Facilitated communication and project progress between CRO, CMO, and testing facilities, ensuring seamless tech transfer and compliance.• Managed analytical testing for GMP release and non-GMP information, supervising OOS event planning with CMOs and in-house.• Skilled in navigating and applying regulatory guidelines (ICH, FDA, EMA, HC) to analytical methoddevelopment and qualification processes.• Designed, evaluated, and presented data while authoring 100+ SOPs, protocols, and technical reports generated from independently executing experimental work plans.• Lead QP and Internal audits by being the representative for the AD Biophysical group.• Responsible for developing annual fiscal budget for analytical development and quality controlactivities/testing for my group in 2022 & 2023.
  • Passage Bio
    Senior Scientist - Analytical Development, Biophysical
    Passage Bio Jan 2022 - Dec 2022
    Philadelphia, Pennsylvania, Us
  • Passage Bio
    Biophysical Scientist - Analytical Development
    Passage Bio Mar 2021 - Dec 2021
    Philadelphia, Pennsylvania, Us
  • Spark Therapeutics, Inc.
    Scientist, Analytical Development
    Spark Therapeutics, Inc. Oct 2019 - Mar 2021
    Philadelphia, Pa, Us
    As an Analytical Scientist in the Biophysics group within the Process and Technology Development Department, I - -Develop, validate, and optimize analytical and biophysical characterization methods to support rAAV process development and product characterization (including SEC-MALS, FFF-MALS, DLS, RP-HPLC, DSC)-Conduct analytical and biophysical experiments to support process and technology development then deliver reliable high-quality experimental data and reports-Collaborate with Upstream, Downstream, PCO, and other departments to determine the best process moving forward with process development based on experimental results-Manage critical samples and prepare critical assay reagents-Maintain GXP compliant good documentation with high level of detail
  • Drexel University
    Graduate Research And Teaching Assistant
    Drexel University Jul 2014 - Sep 2019
    Philadelphia, Pennsylvania, Us
    PhD student in the Biophysical Chemistry group under the guidance of Dr. Reinhard Schweitzer-Stenner. Through my graduate career I:• Explored spectroscopic and physical properties of small and medium peptide chain gelators • Determined secondary structure of amino acids at different pH states in water and with the addition of cosolvents • Explored the kinetic and thermodynamic properties of short peptide hydrogels formed by unlike co-solvents and pH states, and tune the formation by varying the parameters • Determined the reversibility and reformation process of peptide gelators • Mentored undergraduate students to explore the influence of co-solvents on the unfolded peptide conformation of peptides • Collaborated with numerous research teams such as Dr. Nicholas Alvarez, Chemical Engineering (Drexel), Dr. Brigita Urbanc, Physics (Drexel), Dr. Bryan Wong, Chemical and Environmental Engineering and Materials Science (UC Riverside), Dr. Harald Schwalbe, Institut für Organische Chemie und Chemische Biolegie (Johann Wofgang Geothe-Universität), Dr. Lihi Adler-Abramovic, Oral Biology (Tel Aviv University), and Dr. Timothy Vaden, Chemistry and Biochemistry (Rowan University) • Courses taught: CHEM 101 & 102, (Lab/Recitation), CHEM 356 (Physical Chemistry for Chemical Engineers – Lab), 357, 358, & 359 (Physical Chemistry for Chemists – Lab/Lecture)
  • Rowan University
    Undergraduate Researcher
    Rowan University May 2013 - Jan 2014
    Glassboro, Nj, Us
    Performed research in the medicinal/bio-analytical lab of Dr. Catherine Yang. My duties were to:• Determine the most efficient process to extract, separate, and purify urushiol from poison ivy utilizing GC/MS and NMR spectroscopy • Collaborate with Dr. Robert Coifman at Allergy and Asthma of South Jersey to prepare a vaccination

David Diguiseppi, Phd Education Details

  • Drexel University
    Drexel University
    Biophysical Chemistry And Biospectroscopy
  • Rowan University
    Rowan University
    Chemistry B.S.

Frequently Asked Questions about David Diguiseppi, Phd

What company does David Diguiseppi, Phd work for?

David Diguiseppi, Phd works for Bioanalysis, Llc

What is David Diguiseppi, Phd's role at the current company?

David Diguiseppi, Phd's current role is Principal Scientist- Analytical Development and Quality Control.

What schools did David Diguiseppi, Phd attend?

David Diguiseppi, Phd attended Drexel University, Rowan University.

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