Laura DeShullo

Lead and manage the technical transfer process for pharmaceutical products between internal teams and external CDMO partners Oversee the development and validation of analytical methods in collaboration with CDMOs to ensure compliance with regulatory standards and product specifications Develop and implement a comprehensive project management program, including processes, tools, and templates, to standardize project execution across the organization.

Led a team of quality control professionals to facilitate testing and GMP release of complex biologics and small molecules, including linker payloads and antibody-drug conjugates Responsible for all activities performed in the Quality Control Laboratory, including raw material and in-process testing in support of GMP manufacturing, release testing for drug substance and drug product, analytical method qualifications and transfers, sample and data management, and stability program management Communicated directly with clients regarding ongoing projects, testing activities, and addressing aberrant results; represents Quality Control in client visits and inspections/audits Served as primary point of contact for internal stakeholders Developed and implemented department goals and objectives, site initiatives, and strategic improvements Maintained awareness of operating objectives, budgets, metrics, scheduling, and future/potential opportunities

Led and managed site-specific and integrated programs on behalf of Abzena clients to support process development, technical transfer, GMP Manufacturing, analytical testing, and IND-enabling studies Maintained client relationships, ensured clear communication, addressed any issues as needed Provided scientific input to support analytical technical transfers, method qualifications, and laboratory investigations Tracked project financials, including budgets, materials costs, and invoicing status Managed programs that involved three different sites through development of linker payload manufacturing and testing, antibody receipt and testing, complex bioconjugations, and analytical evaluation Ensured client needs were met throughout the program lifecycle, assessed potential risks and associated impact Presented regular program updates to site and company leadership Authored and reviewed documentation as needed to move projects forward

Manage complex customer technical inquiries regarding Active Pharmaceutical Ingredients Effectively communicate with customers and lead technical calls Provide science-based solutions using chemistry knowledge and practical application of analytical chemistry, respond to comments from Health Authorities Coordinate analytical transfers to customers and contract laboratories Author and review technical documentation, including technical packages Manage customer-centric projects

Lead analytical transfers between global manufacturing sites Plan, develop, and execute overall analytical transfer strategy, evaluate key documentation Identify technical, regulatory, or procedural gaps prior to initiation of analytical transfer Author technical documentation including protocols and reports related to method qualification that may serve as source documents for regulatory filings Ensure compliant qualification of all methods at receiving laboratory, adhere to regulatory guidelines Coordinate required materials, reference standards, and equipment as needed Provide support and guidance during execution of analytical transfer, troubleshoot any issues that arise Review receiving laboratory documentation, including specifications and methods. Author additional technical documentation as needed Perform analyses as needed in support of Research and Development or existing production (HPLC, GC, HPLC/MS, XRPD, PSD, FITR) Serve as analytical liaison on cross-functional project teams, communicate with different departments to optimize implementation strategy for analytical methods and technology Provide customer support for analytical inquiries

Perform analytical chemistry work necessary to evaluate the identity, purity, quality and strength of materials by adhering to validated test methods and procedures and interpreting generated data Provide analytical support for plant investigations, design experimental approach to solving manufacturing issues and identifying root cause, communicate results across departments Write and review GMP documentation related to analytical technical transfers, method validations, method development, technical documents, and reports Comply with environmental, health, safety, and regulatory guidelines related to controlled substances and laboratory work Coordinate and conduct analytical method transfers and validations for External Manufacturing and Quality Control Troubleshoot advanced instrumentation, perform routine maintenance on HPLC, UPLC, UPLC/MS, GC Interact and cooperate with process group members, engineering group, Operations, and QC to generate solutions Manage analytical portion of plant validations and plant programs, present analytical data to determine path forward Train new and experienced scientists and co-ops on various analytical procedures, instrument operation

Performed final product testing on active pharmaceutical ingredients to determine chemical content and physical properties Reviewed final product testing for accuracy and completion, ensured cycle time was met Performed assorted testing on active pharmaceutical ingredients, raw materials, and in process samples to assess purity, stability, and other characteristics Documented all data and results according to cGMP, generate accurate and detailed records; communicated results via information systems to maintain efficiency in the manufacturing process. Adhered to all procedural requirements for controlled substances in the laboratory as regulated by organizations such as the DEA and FDA Utilized complex instrumentation including HPLC, GC, UPLC; troubleshooted and conducted minor maintenance or repairs as necessary Rigorously followed all Standard Operating Procedures involved with any analysis to ensure safety, environmental compliance, and correct technique Supported new product and equipment validations that required additional testing Trained new and experienced analysts on various analytical procedures, instrument operation Appointed Team Lead of intermediate product teams, coordinated all testing across shifts to ensure accurate testing within 6 or 10 day cycle time, communicated with team members to conduct investigations as needed Executed intermediate precision aspect of a method validation for one of the newer products on site Conducted method equivalency studies to allow for greater flexibility in equipment usage Prepared for a successful laboratory-focused FDA audit

Conducted extensive laboratory testing on the variety of products manufactured by the company, including pharmaceutical microcrystalline cellulose and food-grade cellulose gum Ensured adherence to sale specifications, including analysis of moisture content, color, particle size, viscosity, degree of polymerization, sieve fraction and speck counts, and concentration of carboxymethylcellulose Entered all data into Laboratory Information Management System worksheets in a timely manner for immediate feedback Investigated results that were out of specification in order to confirm reliable data was collected and procedures were properly followed; determined possible origin of problem or reason behind deviation Monitored environmental conditions in accordance with state law, including wastewater treatment, scrubber solids, and residual solvents in waste water, which required GC analysis Completed work requests as needed, generally extra testing on current products or past composite samples, contributed to the evaluation of recent composite samples Solely accountable for accurate completion of all required testing on both in-process and packaging samples; strategize most efficient approach.

Utilized aseptic technique to perform microbiological analysis on cellulose products in accordance with USP <61> and <62>, including total aerobic microbial count, total yeast and mold count, total coliform count, plant water testing using membrane filtration, and isolation/identification of E. Coli, P. aeruginosa, Salmonella, and S. aureus Applied knowledge of differential media, colony morphologies, contamination control, and negative controls to prove absence of particular microbes Familiar with GMP, pharmaceutical and food safety standards, and policies/practices regarding safety in both laboratory and manufacturing environments

Synthesized and characterized Mn-doped Zn2SO4 phosphor nanoparticles , utilizing primarily ultraviolet spectroscopy and luminescence studies to determine optical properties in relation to Mn concentration Assisted professor with several other projects after synthesis equipment malfunctioned while maintaining independent work environment