Lead a team of 6 engineers and scientist developing Fork & Good's adherent cell bioprocess.Designed and implemented aseptic mammalian cultivation pilot processes to SIP/CIP BioreactorsTranslated spheroid suspension culture wetlab performance to non-stirred tank perfusion benchtop and stainless-steel pilot bioreactors. Established the Bioprocess Team and relevant workflows from early screening to pilot production. Led process development efforts to boost yields by 50% through accelerated cultivation. Successfully demonstrate growth of genetically engineered cell spheroids from bench scale pilot bioreactorsManage and delegate multiple upstream process development projects improving biomass productivity and mitigating at-risk processesProject manager for overall regulatory and tech transfer strategy for Fork & Good's cGMP operations, aligning multiple stakeholders on changing priorities.Led troubleshooting efforts on hardware and process control strategies for benchtop and pilot control loops. Advise and execute design of experiment (DoE) studies interpreting data to identify critical process parameters for manufacturing. Spearheaded cross-functional strategy for perfusion media development, leading to process improvements on titers and reduced manufacturing costs.Identify and implement new process analytical technologies (PAT) and cell processing technologies to increase efficiency of perfusion batch performance. Manage external collaborators and CDMOs supporting Fork & Goods scale-up efforts.

Independently lead research operations on genetically engineered suspension spheroid cell culture in benchtop bioreactors.Optimize aggregation performance through shake flask, spinner flask, and bioreactor culturesImprove efficiency of perfusion filtration performance investigating ideal microfiltration and ultrafiltration hollow fibers for spheroid cell culture.Optimize data analysis workflows from raw data to statistical analysis software via Benchling platform. Author, consult, and execute qualification and commissioning protocols IOQ/PQ.Author SOPs, protocols, and policies for bioprocess team.

Execution of fed-batch and perfusion of upstream spheroid suspension cell culture expansion on small scale benchtop 0.125-0.25L and research scale 0.5-0.75L. Optimization of PID parameters for small scale perfusion bioreactors with alternating tangential flow pumps (ATF). Maintenance of adherent cell cultures from 2D to 3D culture platforms. Optimization of 3D growth of cell spheroids via shake flask, ultra-low attachment plates, and spinner flasks. Rapid prototype via SLA or FDM of custom 3D culture components to evaluate 3D adherent cultures.

Provided primary leadership for:• Preclinical and R&D strategy for stability feasibility studies• High level strategies for release assay design and process development• Ex vivo models for R&D and Preclinical use.Primary Responsibilities Include:• Model development and surgery in acute swine preclinical models• Study Sponsor for outsourced preclinical studies• Draft, finalize, review, and submit IACUC protocols• Maintaining IACUC dialogue for preclinical studies• Design and execute in-house benchtop assays to link in vitro and in vivo efficacy• Monitor activities at CROs; provide technical support, operational oversight, and troubleshooting• Write and edit documents generated internally or at CROs, ensuring excellent communication of study results to internal or external regulatory agency. Such reports could include: mechanism of action or technical reports, as well as protocols, manuscripts, and regulatory documents in the context of assigned preclinical projects

Provided primary leadership for:• R&D testing plans for product stability, vendor diversification, and manufacturing process.• Design related projects associated with process development.• Sterilization validation and stability studies for natural derived polymers.• Safety Committee (Vice Chair)Designed, executed, and consulted on:• Process development studies and strategies to optimize final product efficacy.• Vendor diversification studies on polymers and syringes for VETIGEL™.• Quality control inspection strategies for incoming syringe shipments.• Custom benchtop assays to evaluate formulation applications.Supervised biomedical engineers and R&D technicians on all R&D related tasks.

Provided primary leadership for:• All preclinical tests of the efficacy of hemostatic products ranging from mild to lethal models.• Process to build small-scale sterile manufacturing suites for stability studies.• Custom applicators for both veterinary- and military-based markets.• Custom VETIGEL™ syringe project for tolerances, material selection, and sterilization procedures. • SME on Form2 printer for in vitro assay development and applicator needs.Designed, executed, and consulted on:• One of the two main release assays for VETIGEL™. • In-house in vitro assays to mimic physiological scenarios. Hired, supervised, and evaluated the performance of research and development interns.

Analysis and optimization of physiomechanical properties of current and future hemostatic products. Designed and constructed in-house in vitro assays to assess macro-properties of raw materials, intermediate and final products. Performed thromboelastography and Sonoclot to observe clotting behavior with raw materials and final product. Analyzed data to further optimize properties of current pipeline formulations. Performed quality control analysis on raw materials and final products utilizing in house in vitro assays and characterization instruments such as FTIR.

Developed and constructed assays to investigate and optimize physiomechanical properties of hemostatic gels. Attended and analyzed in vivo studies to further optimize gel properties. Obtain viscosity data from gel candidates for manufacturing purposes. Utilized FTIR to confirm composition changes of gel candidates.

Design and develop a co-culture enthesis bioreactor for tissue engineered menisci. Harvest and utilize natural occurring materials such as collagen and bone. Modeled enthesis bioreactor with Solidworks software.

Learned and applied protein purification and analytical techniques for the downstream purification of biopharmaceutical proteins. Techniques include 1D and 2D electrophoretic separations, western blot, ELISA, affinity chromatography, and IEF. Proteins were characterized via DeCyder software and fluorescent/non-fluorescent dyes. The overall data during the summer was presented to the Syracuse site and also company wide through a teleconference.

Undergraduate Researcher for the Cooper Musculoskeletal and Translational Tissue Engineering Research Lab at the Center for Biotechnology and Interdisciplinary Studies.Encapsulated cells in a hydrogel based matrix for cartilage based tissue engineering studies. Maintained a perfusion bioreactor for cellular based studies.

Inventoried medical instruments.Assisted in routine maintenance of medical devices.Participated in monthly meetings with other VA sites.

Participated as an undergraduate research assistant in a biomedical immunological research lab. Primary research focus was with rheumatory arthritis and asthma in mouse in vivo models. Harvested lymphnodes and spleens to obtain immunological data. Performed ELISA and Western Blot to analyze proteins within immunological studies.