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 interdisciplinary CMC project teams, and serving as a subject matter expert in analytical development. • 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. • Managed aggressive timelines. Communicated program needs and updates. Prioritized work to meet milestones. • Provided forecasts for resource/budget planning and scenario builds enabling high-level business decisions. • Enabled clinical supplies for multiple programs. Drove GMP readiness activities internally and at CROs. Supported GMP manufactures and managed release/stability/characterization testing and data tracking. • Developed comparability strategy for implementation of a new vendor for a critical starting material, providing the company with significant cost savings and ensuring a robust supply chain. • Collaborated on end-to-end control strategy for a critical starting material and established company’s position for impurity findings to evaluate/mitigate risks to ensure patient safety.

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. • Build and drive program timelines. Prioritize and coordinate testing to meet program needs and enable decisions. • Support GMP manufactures and drive release, stability, and characterization testing. • Monitor, trend, and interpret development and GMP data. Lead investigations for out of specification and out of trend results. Help teams troubleshoot issues. • Prepare analytical sections of regulatory documents, filings, and response to agency questions. Participate in agency meetings. Experience with CBER and EU agencies. • Oversee critical documentation generation, approval, and archiving; assay procedures, testing protocols, critical reagent management, clinical expiry, and other strategic and quality documents. • Mentor new coordinators and analytical leads. Knowledge sharing and upskilling future leaders. • Provide input to management to enable resource, forecasting, and pipeline prioritization assessments.

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 methods, and evaluating new technologies. Performed DNA extraction and purification, PCR amplification, and sequencing analysis including qPCR and methylation analyses. • 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 increase PCR success rate for low concentration and highly degraded samples. • 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 crystallization trials, activity assays, and biochemical high throughput screens. Characterized proteins using biochemical and biophysical techniques and optimized purification processes to meet requirements of purity, quantity, activity, and solubility. • 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