Sam Mallonee Email & Phone Number

Minneapolis, Mn, Us

Novato, California, United States

• Responsible for analytical method lifecycle management for adeno-associated virus (AAV) gene therapy programs, including method development, optimization, qualification, transfer, and validation. • Serve as subject matter expert (SME) in regulatory inspections. Present on analytical capabilities to regulatory inspectors, answering questions and ensuring successful inspections.• Author regulatory filings including IND/IMPD, and BLA/MAA (Module 3). Provide responses to agency questions during application review.• Perform audits of contract testing organizations (CTOs). Summarize audit findings and perform gap assessments to ensure compliance.• Develop product quality risk assessments for assessing analytical method capability, risks, and proposed mitigations.

Novato, California, United States

• Interacted with analytical sciences, process sciences and process validation teams to develop, qualify, and transfer assays into the QC laboratory under quality by design (QbD) principles. Authored protocols, analyzed and compiled results, and authored reports. Ensured methods met their intended use.• Designed and authored method validation protocols and reports in accordance with ICH Q2(R1) guidelines.• Authored protocols and reports for special product/process characterization testing to support regulatory responses, including assessment of AAV quantification by qPCR, ELISA and SEC.• Participated in annual product reviews (APRs) for informing upper management of significant analytical method updates and method performance trends.• Contributed to progression of deviations, led laboratory investigations (including OOS, OOT and OOE results). Worked with QA and Regulatory Affairs departments to ensure agreement with deviation/investigation conclusions.• Mentored analysts to improve their technical knowledge and GxP acumen. • Contributed to data review and authorization of results.

Novato, California, United States

Novato, California, United States

• Participated in method transfers, qualifications, and validations or verifications. Authored new SOPs and revised existing SOPs. • Participated in various studies aimed at troubleshooting/optimizing method SOPs or investigating atypical results. Authored detailed reports on work performed.• Organized and executed forced degradation studies for testing product stability under stress conditions, such as thermal, kinetic, oxidative, acidic/basic, and photolytic conditions.• Developed, Qualified and Validated an SEC-HPLC assay for AAV titer quantification of process intermediates to significantly reduce turnaround time and improve manufacturing efficiency.

• Performed testing on a range of samples, including commercialized therapeutic enzyme drug products, powdered drug substances, tablets, synthetic intermediates and gene therapies.• Served as quality product coordinator for multiple products. Responsible for setting stability programs and ensuring all release and stability testing were performed.

La Jolla, Ca

Undergraduate researcher in the Seth Cohen Laboratory in the field of metalloprotein inhibitors. Researched and synthesized appropriate fragments to be used in fragment-based drug discovery (FBDD) libraries.

Palo Alto, Ca

Worked as a coach alongside other coaches at youth baseball camps at Stanford University

Bachelor Of Science (Bs), Chemistry

Certificate, Professional Program In Regulatory Affairs