Anna Tust Email & Phone Number

• Provide support for preclinical pharmacokinetics/toxicokinetics Module 2 written and tabulated summaries, sub-reports, abbreviated reports, and scaling reports
• Provide support for chemistry, manufacturing, and controls Module 3 documents included in regulatory filings
• Actively draft, manage and execute revisions to precision medicine method documents and validation reports, and fully execute corrections required subsequent to QC review
• Perform editorial and document QC review… Show more
• Perform editorial and document QC review for IND, CTA, BLA documents, pharmacokinetic and toxicokinetic reports
• Author and edit scientific manuscripts

Philadelphia, Pennsylvania

• Led coordination of preclinical GLP and research studies in rodent and NHP models, including record keeping and review, ownership of data entry and accuracy into electronic database, and translation of raw data into.
• Drafted and reviewed study protocols, deviation and amendment documents
• Developed and led initiatives for regulatory compliance and training, including drafting and reviewing Standard Operation Procedures
• Prepared facilities for… Show more
• Prepared facilities for inspections and audits
• Lead member of LIMS implementation team focused on process flow and system validation Show less

Philadelphia, Pennsylvania

• Led development and implementation of new systems for sample management
• Oversaw sample management of vector lots, testing samples, cell banks, and plasmid lots for the Analytics and Manufacturing Departments
• Maintained billing database for sponsors through 2018 Fiscal year
• Responsible for generation of Certificate of Analysis for vector product lots
• Trained to assist with analytical assays

Master'S Degree, Regulatory Affairs

Bachelor'S Degree, Biology

Activities and Societies: Women's Lacrosse