Qiuhong (Iris) Yang Email & Phone Number

Chapel Hill, NC, US

Alameda, California, US

Alameda, California, US

Pleasanton, CA, US

• Supported formulation and manufacturing process development for three small molecule oral drug projects (Phase 1 - 3).
• Supervised and managed CMOs and developed robust formulations and processes to support clinical studies. Reviewed batch documents (MBRs, EBRs, protocols, and reports). Interacted with internal QA team and CMOs in.
• Managed CPOs and developed develop packaging systems (bottle & blister) for oxygen sensitive products.
• Authored regulatory documents, e.g., CMC sections of CTD and supported regulatory filings (IND/NDA) and supported the responses to queries from various regulatory agencies for market authorization of Inqovi
• Designed, executed, and analyzed results from laboratory tests and experimentation to advance formulation & process development of immediate release and modified release dosage forms.

Pleasanton, CA, US

Pleasanton, CA, US

• Formulation & process development, technical writing, and regulatory CMC writing.
• Analyzed data and authored technical summary reports to support phase appropriate formulation & process development studies for injectable and solid oral dosage projects.
• Performed literature review and authored summary reports.
• Assisted in revision and formatting for IND amendments and IMPD amendments.
• Drafted drug product sections per CTD requirements to support NDA submission of injectable drug product and Fixed dose combination (FDC) tablets.

Boston, MA, US

• Performed and optimized the fabrication process development of a therapeutic peptide containing microneedle device for transdermal delivery. Coordinated manufacture, analysis and in-vitro evaluation of the microneedle.
• Performed solubility, drug excipient compatibility and stability studies of a therapeutic peptide and developed both liquid and solid forms formulations.
• Developed a therapeutic peptide-containing formulation for the fabrication of a solid-state, microneedle-based delivery device to meet targeted peptide delivery.
• Applied design of experiments principles to optimize the fabrication process of the microneedle device to minimize manufacturing defects, and evaluated in-process stability of API.
• Interacted with various cross-functional teams: manufacturing, analytical development, and preclinical research

• Conducted pre-formulation studies of a small molecule anticancer drug and developed parenteral lyophilized formulations. Performed researches on stability and compatibility of the drug product. Analyzed data from.
• Increased drug concentration 30-fold in a lyophilized formulation through the combination of pH adjustment and complexation.
• Optimized a formulation process to reduce the process-related impurities.
• Interacted with external laboratories and CMOs for GMP manufacturers.

San Carlos, California, US

• Optimized extraction procedure of drug molecules from liposome formulations and performed the analytical assay for quantification.
• Conducted drug release studies.

Lawrence, KS, US

• Synthesized theranostic nanoagents to target lymphatically metastasized cancer. Investigated antitumor efficacy of hyaluronan-cisplatin nanoconjugate in preclinical animal models of melanoma. Designed and conducted.
• Developed an efficient PEG-lipid-based polymeric micelle formulation with increased drug solubility and stability for cabozantinib delivery.
• Developed a formulation of biocompatible core/shell-exchanged coupled magnetic nanoparticles as novel theranostics agent that demonstrated enhanced antitumor efficacy in breast orthotopic tumor model.
• Synthesized novel high molecular-weight hyaluronic-deferoxamine nanoconjugate that exhibited sustained delivery of API and reversed radiotherapy-induced pathologic effects.

South San Francisco, California, US

• Investigated effects of micellar solutions on ring-opening hydrolysis kinetics of small molecule models for ADCs linker.Key Accomplishments:
• Screened favorable conditions to formulate three surfactant micellar solutions.
• Designed a kinetic study to evaluate the surfactant-dependent stability of study compounds.
• Established analytical methods to detect parent compounds and their derivatives.

Memphis, Tennessee, US

Performed animal behavior training and testing, tissue harvesting, and histology. Supported animal surgical procedures; documented, recorded, and evaluated lab results on all performed experiments; and ensured compliance with university policies and laboratory procedures, including maintaining the cleanliness of lab equipment, instruments, and work area.

• Wrote IQ, OQ, and PQ protocols and executed validations for manufacturing equipment and facilities on site; prepared records and reports. Coordinated activities of quality control and manufacturing. Performed.
• Validated heating, ventilation, and air-conditioning (HVAC) systems, water systems, autoclaves, dry-heat sterilizers, and packaging equipment.

• Researched, negotiated with, awarded contracts to, and managed consultants. Coordinated internal and external auditing. Maintained database and records.Key Accomplishments:
• Assisted CTO in developing and implementing quality management systems to ensure conformation of products and services to ISO 9001:2000 requirements.
• Obtained internal auditor certificate.

Doctor Of Philosophy (Ph.D.), With Honor, Pharmceutical Chemistry

Bachelor'S Degree, Bioengineering