Alan Cronk

Worked on various study requests from development groups across Cell and Gene Therapy. Provided data on clinical samples for various programs, including studies involving CDP,APH, and vector samples.

Established a molecular lab workflow to ensure accurate and robust testing was performed.

Was the lead analyst for all studies related to lentivirus vector, ensure that proper handling of virus was performed for operator safety.

Lead molecular analyst for Clinical QC team. Work extensively with analytical development colleagues for technology transfers and method improvements prior to transfer into the clinical QC space. Implemented several ddPCR assays including on-target gene editing and translocation assays for gene therapy programs as well as vector copy number (VCN) and identity assays for cell therapy programs. Involved with method transfers for AAV vector release within QC, including genomic and infectious titer.

This role has also included opportunities to grow additional lab skills such as release Flow Cytometry assays and impurity assays. As well as opportunities to lead the Clinical QC team with general improvements to business practices and workflow.

Responsible for clinical release testing of cell and gene therapy projects. Release testing in a variety of molecular pathways including DNA isolation, qPCR, ddPCR, and ELISA. Also trained on and qualified release methods surrounding cell culture for in process vector manufacturing.

Led testing within the GMP commercial microbiology lab for the Syracuse BMS site. Implemented and qualified new methods for both endotoxin and genetic sequencing of bacteria and molds. Created raw material testing standards used for multiple BMS sites and helped to implement automation within the various labs.

Tested as an analyst within a GMP commercial microbiology laboratory. Completed on-time commercial testing within areas such as bioburden, endotoxin, microcount, PCR based MVM virus testing, and genetic sequencing for molds and bacteria. Completed all raw materials testing for manufacturing as well as water testing for the site.

Created media, reagents, and supplies for a GMP commercial microbiology laboratory. Operated several labs alone to accommodate the needs of a 24/7 micro team and insured that all commercial testing was performed adequately and on-time.