• Built out a process development lab from scratch, including multiple FPLCs, filtration and other lab equipment, general lab supplies, and consumables.• Developed a platform process to purify AAV9 from crude lysate, including clarification by depth and membrane filtration, ultrafiltration and diafiltration (UF/DF) by tangential flow filtration (TFF), affinity capture, full capsid enrichment by anion exchange (AEX), nanofiltration, concentration and formulation by TFF, and final filtration.• Leads downstream group that performs experiments to continue to optimize the process, as well as troubleshoot issues that arise in operation of various unit operations.• Evaluate new constructs in the platform and adjust operating parameters as needed.• Built out a GLP pilot lab capable of purifying a 200-L stirred tank bioreactor. Activities included scale determination, equipment procurement, fluid management, and waste consideration.• Prepared for 200-L GLP productions by drafting, reviewing, and revising batch records, SOPs, and working instructions. Successfully executed on the batch records to purify drug substance and drug product for pilot toxicology studies.• Collaborate with external CDMO partners to develop and transfer processes to manufacture AAV for non-clinical and clinical studies.• Manage direct reports to help them meet their goals and ensure they continue to develop professionally.

• Led development of a late-stage monoclonal antibody purification process. Tasks included establishing a development timeline, devising the development strategy for each unit operation, designing and executing experiments, coordinating analytics and analyzing data, and providing timely updates to the project team and the rest of the purification group.• Developed various polishing chromatography steps in bind/elute and flowthrough mode, including a cation exchange (CEX) step to clear a product-related impurity and an anion exchange (AEX) step. Activities included screening binding and elution conditions in a plate format, dynamic binding capacity (DBC) determination, and condition scouting for gradient and step elutions.• Developed and optimized a depth filter-based whole cell harvest for a high cell density GMP antibody process. Optimized the same harvest operation for use in a platform antibody purification process.• Led successful early-stage viral clearance study campaign, including coordination, preparation, execution, and follow-up. Unit operations studied were Protein A capture, low pH viral inactivation, mixed mode-anion exchange chromatography in flowthrough mode, and virus retentive filtration.• Performed analytics as needed, such as HPLC titer, SEC-HPLC, ELISA, and LabChip CE.• Generated documentation of all laboratory activities including electronic lab notebook (ELN) and reports.• Supported tech transfer activities as a subject matter expert (SME) including batch production record review and person-in-plant (PIP) when required.• Performed high-throughput purification of samples for analysis using the Hamilton liquid handler.• Supported lab efficiency by 5S organization and freezer inventory development. Served as lab safety rep.

• Designed and executed experiments to improve and further understand a platform downstream process developed to purify lentiviral vector (LVV) produced in a suspension cell culture-based transient transfection process. Unit operations studied include harvest by depth and membrane filtration, other membrane filtration steps, capture chromatography, ultrafiltration and diafiltration (UF/DF), and formulation.• Supported the start-up of in-house pilot-scale capabilities. Performed scale-up experiments and purified LVV at the pilot scale to support scientific investigations of the full-scale process.• Performed subject-matter expert (SME) duties for technology transfers to external manufacturing partners by generating and reviewing batch records and reports, training operators, acting as person-in-plant (PIP) during establishment and scale-up runs, and coordinating analytical testing of process retains.• Managed a co-op student. Trained the student on the unit operations and associated data analysis, designed experiments, advised the student’s projects, and guided the student’s professional development.

• Executed experiments to improve the robustness of the process used to purify suspension-derived LVV.• Performed routine bench-scale purifications to support upstream process development.• Assisted in the development of a high-throughput purification method using the JANUS liquid handler.• Participated in a technology transfer by generating and reviewing batch records and acting as (PIP) for PD activities at external manufacturing facilities.

• Produced research-grade LVV on the scale of 2 L to 10 L for in-house research. Production duties consisted of entire upstream and downstream processes, including buffer and media preparation, adherent cell culture and transfection, harvest, capture chromatography, UF/DF, and sterile filtration.• Performed cell-based titer assay and other necessary analytics on all final LVV products manufactured in the group.• Supported the group as needed with other analytics such as ELISAs and qPCR assays.

Project objective: To scale up a Hepatitis A virus production process from roller bottle scale to single-use bioreactor scale, in which mammalian cells are grown on microcarriers.- Growing, feeding, and passaging an attachment mammalian cell line in T-flasks.- Running experiments in spinner flasks, a 1L glass bioreactor, and 3- and 15L disposable bioreactors.Project objective: To test a novel online glucose sensor developed by designers in industry for use in bioreactors.- Performing bioreactor runs to the specifications of industry colleagues, with both E. coli and CHO systems.- Recording online readings, offline glucose measurements, and other parameters relevant to operation.- Writing reports discussing protocols, results, and future directions, and conferring with industry colleagues.EHS Duties: Weekly safety inspections, assigning required lab member training, and keeping updated records.

Project objective: To fully characterize a single pass tangential flow filtration (SPTFF) unit for incorporation into the manufacturing process at the Bristol-Myers Squibb Syracuse site, to decrease holding volumes of product.- Determined that feed pressure and feed concentration can control the Volume Concentration Factor (VCF) and volume flux, which are the important characteristics of the process at the Syracuse site.- Found that VCF and flux can be adjusted to fit the current process without damage to or loss of protein product.- Monitored performance over time; found no trend or indication of deteriorating performance over several weeks.- Concluded that system could be successfully incorporated into manufacturing processes.- Presented results of study to Manufacturing Support group and others, including the Syracuse Site Manager.

Project objective: To develop a product to quantify a specific genus of bacteria in a sample of water- Designed experiments to determine the material and platform geometry most conducive to bacterial growth.- Tested new antibiotics, in a design of experiment setting, to allow growth of the target bacteria but kill other bacteria.

Project objective: To determine the tautomeric role of certain metals in the mutagenesis of DNA.- Mixed and autoclaved several types of bacterial media.- Inoculated and infected E. coli cells with M13 bacteriophage in environments including different salts and metals in order to determine how well these viruses grew in each environment.- Centrifuged out lysed bacteria, infected new E. coli with the bacteriophage, incubated on agar plates, and later counted resulting plaques of viruses.- Ran Optical Density tests on E. coli to determine how the salts affected the growth of the bacteria.

Project objective: To automate the diagnosis of Alzheimer's disease by writing programs able to count and identify neural cells and determine the range of focus of a sample on a microscope slide.- Captured images at varying depths through a sample under a microscope, called an image stack, on which the developers ran programs.- Counted and marked cells in images and determined the range in which the pictures were in focus in order to double check the computer programs.- Ran the programs on image stacks, analyzed the results, and submitted them to the project database.