Alan Stoumen Email & Phone Number

Conroe, Tx, Us

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 Improved productivity and performance efficiencies in all QA/GDP/GMP documentation and administrative tool/systems, including: Deviations, CAPAs, LIRs, CCs, SOPs and analytical test methods and data analysis and reporting. Ensure adequate number of QC team members have completed deviation training to support investigations.Supervise and direct activities in accordance with internal QA, cGMP, regulatory and BSL-2 safety requirements. Direct QC laboratory organization, supply maintenance and recordkeeping duties.Task Assignment, Scheduling and Revenue Actualization Management. Set the team up for success by directing weekly QC meetings. Work with other department leaders to coordinate efforts in support of QC analytical testing for all client cell therapy product process/production runs (MFG, QA, Product Development, Process Development).Supervise the Cell Based Assay (CBA) group in the development, transfer, qualification, validation and performance of a variety of cGMP bioassays to support characterization and potency assessment of cellular and protein therapeutics for clients. Consistent record of leading cross-functional teams in the implementation of innovative biomarker, cell-based, immune and enzymatic assays in support of preclinical, clinical, stability, and product release studies.

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 implemented optimization plan that increased performance from 25% to 90%, met %CVs system suitability criteria and enabled continuation of release and stability testing program, meeting revenue actualization targets.➨ Troubleshot low percent recovery for client ELISA method by implementing dilutional linearity testing that reduced HSA concentration in product matrix and enhanced recovery from 20% to 80%. Expanded use of assessment to ELISA methods for a variety of formulations, patient dosing, and delivery systems.

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 programs over a one year period.➨Transferred laboratory operations to new laboratory and established regulatory protocols and procedures to conduct cell-based assays and residual DNA assays. Led change of equipment ownership, defined processes for new lab and restructured group through hiring of two specialized scientists.➨ Spearheaded installation and implementation of TECAN automated liquid handling robotic platform and provided staff training. Developed and implemented residual HCP assay method, programming and automatic method optimization that significantly slashed labor costs in process development. ➨ Directed team through development, qualification, and implementation of transient transfection test method for residual plasmid DNA, enabling KBI to expand corporate portfolio with a new offering.➨ Partnered with business units and technical teams to gather information on development and testing needs from clients and delivered customer-centric presentations to bring new business to KBI.

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 the ground up, optimized and implemented a high throughput small-scale purification method for Mab samples. ➨ Optimized automated method parameters for maximum capture and recovery of IgG with efficient removal of nucleic acids and other contaminants. ➨ Implemented automated protein purification system that provided equivalent yield and purity as bench-scale purification development column for a greater number of samples in less time.

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 isolation/PCR Cleanup) /CPE) and automation with liquid handling systems including Tecan Evo, Biomek2000/3000, FX, Qiagen 3000/8000/9600, Invitrogen iPrep, and ThermoFisher KF 96.

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 increased sample testing throughput and staff productivity while ensuring FDA compliance of automated audit trails, sample barcoding and sample tracking across platforms; standardized hardware and software, data analysis software and protocols.➨ Disseminated company automation accomplishments by presenting on Automated Assay Workflows and 21 CFR Part II Compliance, at international AAPS conference: Automation of Ligand Binding Assays to Support Demanding Drug Development Programs.

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 transfer of assay kit reagents, cell protocols and methods from manual to automated operations. ➨ Simulated HTS of targeted compound libraries to support new products and build compound profiles across product portfolio; contributed authorship to marketing collateral/technical notes on automation of high content screening assays and cell motility procedures.

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 Metamorph software). ➨ Delivered assay miniaturization and transformed manual operations into automated 48-well, 96-well and 384-well assay plate HTS format, with increased assay efficiency, throughput, accuracy and precision. Results from beta-testing of Universal platform system were used by vendor as proof of concept to advance to the final systems design and software version upgrades. *** Earlier Roles *** Research Associate III─ Biology | Cell Pathways | 1995 – 2000Senior QC Associate ─ Bioassay Testing | Synergen | 1991 – 1995

M.B.S., Behavioral Genetics

B.A., Biology, General