Gary Shea Email & Phone Number

Boston, Ma, Us

Cambridge, Massachusetts, Us

Led design and implementation of a GMP-compliant program management system for clinical drug substance tech transfers, ensuring product lifecycle control and successful new therapy launches.Developed project management systems that streamlined operations and reduced emergency documentation requests by 31%.Fostered cross-functional collaboration to improve CMC process clarity by 82%, resulting in smoother workflows and on-time delivery.Successfully managed audit commitments, manufacturing suite improvements, and documentation initiatives, ensuring regulatory compliance and product quality.

Waltham, Ma, Us

Waltham, Ma, Us

Managed the entire HIVE™ product development lifecycle, from pre-feasibility R&D through commercialization. This encompassed quality assurance, manufacturing optimization, technology transfer, contract manufacturer management, and marketing/commercial strategy.Built and led cross-functional teams to drive product development from concept to launch. I successfully navigated the stage-gate process, ensuring alignment with project goals and timelines.Established and maintained robust quality systems and process control plans for device and reagent manufacturing, ensuring compliance with industry standards and regulatory requirements.

Waltham, Ma, Us

Optimized the molecular biology workflow for a proprietary single-cell RNA sequencing (scRNAseq) platform, increasing efficiency and data quality.Developed and standardized reproducible protocols for scRNAseq, from component manufacturing and assembly to consumer use, enabling consistent and reliable results.Implemented process improvements that reduced the scRNAseq assay cycle time by 25%. This was achieved by installing and validating high-throughput plate readers, utilizing 96-well vacuum filter plates, and developing automated calculation and documentation tools.

Enschede, Overijssel, Nl

Invented and developed a novel platform for high-throughput shape-controlled microparticle manufacturing (patent pending: U.S. Provisional Application No. 62/869,871; NL N2027000) with broad biomedical applications in drug delivery, tissue engineering, and cell therapy.Designed and executed experiments to validate a theoretical chemical kinetic model for high speed photopolymerization, deepening understanding of reaction mechanisms and enabling precise control for future applications.Conducted extensive literature review in tissue engineering, cell encapsulation, and cell-biomaterial interactions, identifying industry challenges and developing innovative technological solutions.

Cambridge, Ma, Us

Engineered a key technical feature of the "Seq-Well" scRNAseq platform, enabling cryopreservation of sample RNA integrity, a critical improvement that established a unique value proposition for Honeycomb Biotechnologies' HIVE product line.Executed molecular biology and engineering assays for collaborative projects spanning multiple institutes, industries, and clinical settings, contributing to diverse research initiatives.

Troy, Ny, Us

Investigated claudin 5 binding peptides for transient disruption of the blood-brain barrier. Performed microarray peptide affinity analysis, mammalian cell culture experience, experiment design, fluorescence imaging and image processing, and data analysis.

Brentford, Middlesex, Gb

Manufacturing Specialist roles include leading process/procedural deviation investigations and reports, process improvement studies, equipment commissioning and decommissioning and controlled documentation revision. Coordinated projects to enhance work order management system which ensured compliance to GMP regulatuons. Gained exposure to both manifacturing and R&D sides of the pharmaceutical industry.

Professional Certificate, End-Of-Life Doula

Master Of Science - Ms, Biomedical Engineering

Bachelor Of Science (B.S.), Biomedical Engineering

Education record