Alan Stoumen Email & Phone Number

Conroe, TX, US

Durham, North Carolina, US

Manage and lead QC-Ops team daily functions such as: reviewing QC Lab documents (equipment logbooks, cleaning logbooks, material ordering). Ensure the QC team is compliant to GLP, GDP, cGMP and EHS safety standards. Oversee the creation of QC team curriculum training and new employee onboarding training to ensure team is in compliance for GMP runs. Manage.

Recruited to develop novel brain-penetrant formulations of lysosomal enzymes for treatment of lysosomal storage diseases. Tasked with establishing tissue culture facility and cellular models, conducting toxicity studies and characterizing formulations via microscopy, immunohistochemical (IHC) and enzymatic activity techniques.

Wilmington, NC, US

Brought in to lead bioassay performance optimization initiatives and expedite completion and report generation for clients’ projects. Managed data analysis, protocol development, troubleshooting, and reporting.➨ Improved assay performance for client cell-based assay method failing precision system suitability criteria for several months. Ideated and.

Durham, North Carolina, US

Led bioassay group to support client projects on development, qualification, and commercialization of potency assays in compliance with international regulations and USP guidelines. Directed cell-based and residual DNA testing in support of product development and manufacturing programs. Scaled workflow and testing for 17+ residual DNA support service.

Billingham, GB

Hired to conduct bioassay development and enhance automation capabilities in support of early-stage programs for protein-based biopharmaceutical production. ➨ Introduced and managed strategies to deliver robust, reproducible and accurate bioassay results and facilitate express transfer to GMP QC laboratories.➨ Built laboratory automation capabilities from.

Provided field support to industry, academic and government client laboratories for automated nucleic acid purification and extraction applications. ➨ Co-authored technical notes outlining increased efficiencies, throughput, and data quality of automated system vs. manual protocols to support product marketing for Invitrogen NAP product line (gDNA/RNA.

Cambridge, MA, US

Led harmonization of Tecan platforms across Cambridge, RTP, and San Diego sites. Aligned system configuration and integration for efficient and compliant clinical Phase III sample testing operations and assay performance. Collaborated with internal team and external vendors to drive systematic automation approach.➨ Enabled efficient lab operations with.

Optimized automation and validation of assay kit products and software systems with Cellomics' ArrayScan and KineticScan cell-based imaging and integrated Beckman Coulter Biomek 2000 and F/X platform systems. ➨ Transferred and scaled bench top/manual methods to automated platform design, layout and methods. Work closely with bench scientists to co-ordinate.

Coordinated interdisciplinary team in the implementation of automated HTS assay and cell-based microscopy technologies to support ribozyme product TVD testing. Collaborated with vendors in the design, implementation, optimization and validation of a Tecan EVO automated liquid handling platform and a Universal Imaging platform (Hudson plate crane and.

M.B.S., Behavioral Genetics

B.A., Biology, General