Focused on process closure and sutomation.Implemented several process changes to streamline operations, improve consistency and lower costs.Clinical and process data review.

Evaluated multiple automated electroporation formats. • Implemented LOVO for buffer exchange, concentration, pre-selection incubation and post-selection exchange.• Optimized Prodigy for selection and electroporation.• Evaluated Sepax and Rotea for multiple process closure and automation steps.• Designed a fully closed manufacturing process and began comparability studies for implementation in GMP production. • Evaluated multiple media options for removal of serum and reduction of high-cost goods.

Cell and gene therapy• Focused on autologous and allogenic cell therapies with clients ranging from pre-clinical through Phase III. Cell-types include CD34s, T-cells and MSCs. Both naïve and genetically modified products. • Responsible for contract review, gap assessments, feasibility assessments, PD, manufacturing support, documentation drafting and review and investigation lead and support.• Daily duties include client-facing external communication, timeline assessments, authoring and reviewing SOPs/Batch Records/Technical Reports and manufacturing personnel training. • Technical assessments and implementation for scale-out (autologous and allogenic) and scale-up (allogenic) of processes.• Automated and closed processes using LOVO, Sepax, Rotea, CliniMACs Plus / Prodigy and G-Rex vessels.• Use of DOE (in Minitab) for implementation of electroporation and critical process parameter identification.

- Bacterial and mammalian protein expression- Transient expression and process improvements- Creation of stable pools- Selection and management of CMO partners

• Autologous stem cell manufacturing, served as regulatory point person• Managed quality control personnel, co-wrote Phase I trial, prepared CMC sections for regulatory submissions, published IND, worked to ensure patient enrollment and release of drug.• Authored SOPs for quality and manufacturing• Coordinated communication between site and CRO

• Mouse models of Autism and the role of the microbiome• Provide microbial expertise for a neuroscience lab focused on behavior responses• Trained and coached junior staff in molecular techniques• Expert level laboratory bench skills for molecular biology techniques, such as qPCR, DNA isolation, cloning and primer design

• Studied germination of the anaerobe Clostridium difficile and how the process can be interrupted for the purposes of drug development• Designed and performed experiments, independently and accurately analyzed and presented experimental data effectively through presentations, project reports and journal publications• Earned Lawrence S. Dillon Award for excellence in research and teaching

Upstream Process Development and Manufacturing SupportMammalian and YeastTech transfer of Pasteurization process from lab to manufacturing and contract siteSupport process transfer to contract site

Upstream Process DevelopmentMammalian and YeastDevelopment of feed based on RQMixing studiesScale up to 20,000L

Upstream Process DevelopmentBacterial and Yeast - Scaled processes from shake-flask to 250L- Media optimization