David Diguiseppi, Phd Email & Phone Number

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.

Philadelphia, Pennsylvania, Us

Philadelphia, Pennsylvania, Us

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

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)

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

Doctor Of Philosophy (Phd), Biophysical Chemistry And Biospectroscopy

Chemistry B.S.