Amy Gallagher Email & Phone Number

• Analytical program lead for rAVV gene therapy projects in early and late phase development. Responsible for developing and managing analytical strategy across the portfolio, collaborating with analytical and.
• Defined analytical control strategies for multiple programs and established framework for platform specification approaches.
• Authored regulatory documents and supported responses to agency questions. Used agency feedback to refine development strategies and gain approval of regulatory filings.
• Provided technical guidance for method development, qualification, and troubleshooting activities resulting in successful development of fit for purpose methods and resolution of analytical issues.
• Contributed to novel technologies evaluations considering technical, business, and regulatory aspects.
• Proactively identified risks and mitigation strategies to develop phase appropriate risk postures for analytical activities including shelf-life strategies, specifications, and comparability studies.

West Point, PA

• Vaccine analytical research and development. Analytical lead responsible for developing and executing analytical strategies and representing analytical at cross functional meetings.
• Analytical Lead for 4+ years on early phase vaccine development programs including novel adjuvant, multi-valent, and RNA based vaccines.
• Successfully lead multiple high priority programs through pre-clinical and clinical milestones with high business impact for driving the pipeline.
• Collaborate with cross-functional areas to drive and influence product development and overall program strategies and timelines with line of site to commercial.
• Develop the analytical control strategy including method/technology selection, method use and siting, and specifications setting. Present specifications to governance committees for alignment and approval.
• Oversee analytical activities to ensure fit for purpose method development and qualifications for GMP support. Evaluate and implement novel technologies.

West Point PA

• Vaccine analytical research and development. Started as a benchtop scientist supporting a wide range of technologies and vaccine modalities, then transitioned into project coordination and leadership positions.
• Benchtop experience in a wide range of technology; SLS, DLS, zeta potential, DSC, AUC, AF4, CD, HPLC, chromatography, mass-spec, NMR, and more.
• Program coordination and sample management experience including shipping, aliquoting, inventory and critical reagent management, forecasting, submissions, and transfers for GMP and non-GMP materials.

• Particle size analysis and biophysical characterization of vaccines, in a GMP environment. Developed and optimized analytical methods to meet client needs for cross-functional deliverables.
• Supported a breadth of methodologies including SLS, DLS, zeta potential, adsorption capacity, DSC, CD, AUC, IF.
• Provided meaningful contributions to client programs. Recognized for exceeding expectations.

• Genomics LabDNA mutational profiling of clinical samples to support a broad clinical biomarker discovery program. Responsible for planning, executing, troubleshooting, and analyzing genotyping experiments, developing.
• Established automated methods, implemented new technologies, and successfully optimized manual methods to reduce sample needs, simplify workflows, increase throughput, reduce turnaround times, increase robustness, and.
• Created and implemented a procedure for returning unused materials to the Biorepository. Allowed for accurate tracking of samples and established a monthly sample return schedule.
• Designed, optimized and validated PCR and sequencing primers.

Genomics Labsee above

• Protein Biochemistry LabProtein purification and characterization of oncology and metabolic targets. Purified recombinant proteins from E.coli and baculovirus overexpression systems to support downstream.
• Purified 50+ protein targets, leading to 30+ solved crystal structures, including 6 high resolution first in-house crystal structures.
• Developed screening process to evaluate which compounds were more likely to lead to co-complex crystal structures, which saved time and resources, and resulted in a 60%+ crystal structure success rate.

Expressed and purified human α-synuclein protein from E.coli cultures. Used mass spectrometry and fluorescence assays to determine the mechanisms of interactions between α-synuclein fibrillation and chemical inhibitors. Determined that chemical analogs modify α-synuclein differently and at least one reactive site is on the N-terminus of α-synuclein.

Certification, Clinical Research Conduct And Management

Bs, Biochemistry And Molecular Biology

Highest Honors GPA 3.85/4.00 Thesis "Regio-Isomers Modify a-Synuclein Differently." Study Abroad, New Zealand, University of Otago, Dunedin