Andy Golden Email & Phone Number

Boston, MA, US

Cambridge, Massachusetts, United States

• Acquired by Ginkgo Bioworks
• R&D Lead for microfluidic cartridge team.
• Drove product and process development including: $1MM+ effort to control assembly of innovative valving approach, shelf life optimization, FDA submission support, and Next-Gen design and breadboarding.
• Lead for lyophilized reagent beads from Phase 0 through manufacturing readiness.
• Managed partnership with lyo CMO including transfer to production line, scale-up studies, 26 lots, master mix formulation / QC qualification, and documentation.
• Led the calling algorithm analysis and optimization through EUA submission.

Greater Boston Area

• Managed the technology development team within engineering.
• Successfully lead feasibility work for modules of microfluidic blood cartridge including plasma separation, bubble handling & reagent mixing.
• Established cross-functional and external relationships.
• Developed new QC tests to support yield / process improvement with Process and Development teams for on-market cartridge.

Greater Boston Area

• Built and managed a small internal team and managed an external partner.
• Successfully led nanofluidic consumable development from academic prototype to mass manufacturable device. Required new QC tests to achieve nanoscale bonding precision for plastic chips (2 pending patent applications).
• Led coating development for single molecule DNA transport, resulting in an unconventional set of coatings and on-board QC tests.
• Hired and managed technical team.
• Developed IP strategy & completed multiple filings.

• R&D manager / team lead for scientific and engineering projects that integrate sample and reagent with the diagnostic consumable.
• Managed collaboration with mechanical engineering / manufacturing department.
• Invented and developed a novel coating and test strip geometry, then transferred technology to factory.
• Led interdisciplinary effort to reduce test strip variability, guided by statistical methods.

Burlington, Massachusetts, United States

• Developed XenoSure bovine pericardial patch for vascular implantation, from product transfer through 510k FDA approval and manufacturing scale-up.
• Designed and implemented suite of chemical quality control tests for chemicals that contact product during processing, fixation, sterilization, and packaging.
• Wrote >50 documents for DHF.
• Invented 3 surgical bioglues, 2 which diverged from competition, filed 8 patent disclosures.
• Implemented design control (21 CFR 820) and ISO 13485.

Fiberoptic picotiter plates for genomic sequencing and other life science tools. R&D and prototype fabrication for customers.

Phd, Biomedical Engineering

Lab Head: Joe Tien, Associate Professor of Biomedical Engineering (tenured), graduate of George Whitesides Lab @ Harvard Thesis.

Presidential Post Doctoral Fellow

External product development collaborator and first end user of the Ionflux, the first-ever commercial implementation of automated patch.

Bs, Mechanical And Aerospace Engineering

BioEngineering Option completed as a concentration. Capstone Thesis: Interactive simulation of a knuckleball pitch in MATLAB