Heather Dorthé Email & Phone Number

San Diego, California, United States

Formulation and method development for mAB and ADC BDS and DP.Led analytical method transfer (validation and qualification) to multiple CDMOs for several projects in parallel. Strong experience in ICH and USP guidelines for analytical method development and qualification. Experience with CDMO selection to manufacture mAb, ADCs and DP.Strong experience with establishing and justifying product Specifications.Strong experience with establishing and executing stability studies.Strong experience with QC QMS systems and controls including change controls, CAPAs, and SCAR risk assessments.Program management experience organizing cross-functional teams to meet annual CMC Regulatory deliverables.Experience writing IND CMC M3 sections.Lead and oversee site-wide ELN users for San Diego office.

San Diego, California

CMC- Analytical Development and Formulation

San Diego, California

CMC- Analytical Development and Formulation. Provide analytical support of all manufacturing activities of ADC bulk drug substance and drug product in an aggressive and time-critical biotech start-up environment.Develop and support pipeline generation including pre-clinical, phase 1 and late-stage development.Develop, qualify and validate chemical and biophysical methods for ADC characterization.Support writing and review of BLA and other regulatory filing documents.Manage relationships with multiple CROs and CMOs for support of GMP activities.

La Jolla, Ca

In this role, I independently developed research strategy and executed high-throughput crystallography experiments for 6+ projects in parallel, utilizing various crystallography techniques including:Liquid-handling roboticsCrystal screeningCrystal optimizationMacro and micro seedingLigand soakingCrystal cryo condition determinationCrystal harvestingData collection and processing at ALS and APS beamlinesFragment-based lead discovery campaignsStructure-based drug discovery methodsI have extensive experience in leadership and management through the following roles:Liaison between labs sites and CROsTrained and managed workflow of lab internsMentored junior scientists

Researched polymer-apatite composites leading to development of potential bone filler scaffold materials - Developed novel fabrication technique of composite microspheres and 3D porous scaffolds - Characterized element composition, dissolution rates and crystalline structure of composite material - Analyzed interconnective pore structure of composite material using SEM and Micro-CT imaging

Worked on analyzing the chitin-protein structure of jumbo squid Dosidicus beaks - Trained and practiced chemical characterization and protein isolation lab techniques - Skilled in precise data collection and organized record keeping

Responsible for weekly lab chores and assisted with experimental procedures - Responsible for original research data analysis, interpretation and presentation - Assisted graduate students with research projects - Prepared stock solutions from concentrated chemical components

Masters Of Science, Biomaterials And Biomimetic Sciences

Activities and Societies: NYU Triathlon TeamTitle: Polylactic-co-glycolide (PLAGA)/Carbonate Apatite (CHA) Composite: Preparation.

Drug Discovery And Development Certificate, Medicinal And Pharmaceutical Chemistry

Bachelors Of Science, Biochemistry-Molecular Biology

Activities and Societies: UCSB Honor Society, UCSB Chemistry Club, Women in Science and Engineering, Volleyball