MS&T Purification Senior Scientist at a small Norovirus Vaccine company specializing in VLPs. - Downstream purification scientist in the Manufacturing Sciences and Technology group working with VLP vaccines at various phases in a cGMP environment. - Leads early purification process development for several Next Generation VLPs in a cross functional team involving lab experimentation and analysis and collaboration with CROs. - Generates criticality assessments, product quality risk assessments, and FMEAs at the CDMO to support large scale tech transfer cross functionally. - Performs gap assessments and design mitigation plans and studies in collaboration with the CDMOs to derisk Manufacturing runs. - Drives design, development and execution of lab studies to support life cycle management and continuous improvement initiatives.Supports ongoing technical transfer and manufacturing at CDMOs through acting as the person in the plant and providing technical oversight to assist with troubleshooting.

- Downstream purification lead of Process Development/MSAT for the oncolytic HSV program. - Part of Process Development/MSAT team for viral RNA program. - Responsible for designing, executing, and analyzing process development experiments for our all our oncolytic virus programs. - Responsible for maintaining accurate GMP quality documents, such as batch records, deviations, and technical report; includes authoring, updating, and post GMP batch reviewing. - Production skills include clarification, column chromatography, TFF, enzymatic reactions, IVT, and analytical testing/characterization. - Works to manage our CMO, which involves PIP and expertise in the purification part of GMP manufacturing. - Responsible for managing and training direct report on lab and manufacturing techniques. - Part of RNA and LNP MSAT team working to scale up the process, troubleshoot and ready equipment for our GMP manufacturing facility. - Part of team to bring our vRNA program to our new GMP facility and fully execute batches.

Responsible designing and executing process development experiments for AAV capsid and vector clarification, column chromatography, depth and normal filtration, TFF, and basic analytical characterization. Performs process data analysis, support the preparation of technical reports, SOPs, internal and external presentations. Lead lab move and reorganization. Coordinates with outside vendors for repair, maintenance, and/or calibration of laboratory equipment and systems.

Designs and executes development experiments and studies for the downstream development lab via various software tools for multiple biologic programs. Part of CMC team for certain projects, while being a project manager. Writing technical reports for experiments performed. Collaborating with analytical and formulation groups for enhanced process development. Working with numerous vendors to determine the most useful technologies based on our needs. Performing virtual PD work for our CMOs and CROs.

Executing manufacturing batch records and support records following GMP practices; Buffer preparation; Operation of AKTA Purification Skid using UNICORN software; Method editing; Installation and handling of single-use components used in manufacturing including sterile bags, filters, and mixing systems. Perform critical process steps using aseptic technique. Perform manufacturing operations by strictly following SOPs and documentation practices. Perform cell culture tasks including sampling, cell counts, disposable bioreactor operations. Packing and qualifying purification columns. Writing and reviewing manufacturing Batch records, SOPs CAPAs, deviations, and other controlled documents. Interacting with other groups, including QA, QC, Validatiom, Engineering, and Material control. Worked in Process Development: Developed small scale operations using AKTA explorer/pilot systems. Analyzed data gathered for process improvement. Tested samples using various lab instruments.

Part of the HA purification team. Responsibilities: Use of pressure tanks for, purification, media prep, fermentation, CIPs, and SIPs. Coordinates validation and engineering studies. Calibration/Metrology liaison. Writes/edits SOPs and other cGMP documents. Trained in Data Entry software

Integral part of a protein purification process involving a new investigation drug. Responsibilities include performing column chromatography and column packing using UNICORN software; performing protein filtration processes in a biological safety hood; writing and editing GMP documents such as standard operating procedures and process instructions; training other personnel on processes and procedures. performing cell culturing processes as part of the manufacturing process.

Provided emergency medical services for five towns in Chittenden County with squad answering 2200 + calls per year. Provided basic life support, immobilization and extrication techniques, performed CPR and AED protocol, knowledge and use of certain emergency drug medications, and ongoing communication between medical personnel and patients.

Learned about physical therapy through shadowing and patient interviews. Acquired understanding of work-related injuries and procedures to assess injuries and determine treatment. Visited various companies to provide information on injury prevention; developed training lecture on carpal tunnel, back pain, and shoulder injuries. Became familiar with medical issues around workman’s compensation.