Experience

DNA Electronics (DNAe)

• United Kingdom
• Biotechnology Research
• 100 - 200 Employee

• Sr. Manager

  • Sep 2021 - Present

  • Drive the development of internally manufactured reagent and cartridge assemblies including creating SOPs, work instructions, batch records, and associated documents. Manage and update product BOMs. Provide alternative solutions to development teams for single sourced or cost prohibitive reagents. • Work directly with R&D teams to development material specifications, BOMs, identify quality control tests, and implement control strategies to ensure conformity to specifications.• Determine user requirement specifications, process control limits, and key process parameters for generating control charts, process capability (Cp, Cpk) and process performance (Pp,Ppk) for IQ/OQ/PQ activities.• Together with QA/RA, manage the design control activities including generation of d/pFMEA documents, risk mitigations, defining required training, and review/edit WI/SOPs to aligns with existing design control processes.• With Operations, perform assessments of internal and external capabilities, identify limitations of existing infrastructure, and provide justifications for additional resources required for pilot manufacturing and V&V activities.• Execute sourcing strategies for critical materials to minimize interruptions in timeline delivery. Negotiate with suppliers to ensure supply continuity and continuous improvements to quality of supplied products.• Create manufacturing and operation plans to align with design and development activities. Generated process flows for make/buy evaluations that identify high risk materials that are requirement dependent. Show less

• Manager, Reagents

  • Oct 2017 - Present

  • Managed 3 direct reports in developing NGS reagents used in a microbial IVD.• Partner with subsystem leads to develop experiments that reduced complex of the assay by 10 process steps and consolidated 51 unique reagents down to 34. • Communicate assay design changes to our system/cartridge CMO and manage the required documentation for change control. • Develop reagent formulation/sterilization processes for 15 of the bench reagents. Implemented facilities changes to accommodate new processes created during program change. • Spearheaded the movement from a paper-based system to a 21CFR11 compliant, ePO system linking procurement, inventory, and quality operations. • Minimized LIMS costs of $3,000 user/year by developing cloud-based applications with existing purchased software capable of collecting data, generating documents, and capturing KPI information from the research experiments. Show less

• Senior Scientist II

  • Feb 2015 - Oct 2017

  • Manufactured 30 gram-scale super-paramagnetic particles (emulsion based, sterile, DNA free) critical in the developmental of the flagship product. • Decreased the cost of goods from $22 to $10 per assay through external vendor negotiations, formulation modifications, and consolidation of internal resources. • Engaged in cross-functional discussion with life science teams on process improvements based on the chemical properties of materials leading to a 48% boost in pathogen detection.• Served as a subject matter expert for reagent manufacturing during audits and potential investor partnerships.• Successfully executed the physical relocation of the Albuquerque manufacturing facility across state lines. Provided input on floor plan design that accommodated for both GMP and R&D operations.• Took an active leadership role in managing reagent manufacturing that generated 1,500 assay/month and helped the technical teams remain on task for meeting immediate deliverables. Show less



Alfred Mann Institute at the Univeristy of Southern California

• Los Angeles, Ca

• Research Associate

  • Jul 2011 - Feb 2015

  • Recruited as a key scientist responsible for the development of a medical device based on reversible adhesive technology. • Performed laboratory experiments supporting the core technology design specifications which lead to a composition of matter patent. Formulated alternative polymers formulations that exhibit the reversible adhesive properties. • Promptly tackled research experiments and generated data critical to project timeline. • Recruited as a key scientist responsible for the development of a medical device based on reversible adhesive technology. • Performed laboratory experiments supporting the core technology design specifications which lead to a composition of matter patent. Formulated alternative polymers formulations that exhibit the reversible adhesive properties. • Promptly tackled research experiments and generated data critical to project timeline.



University of Southern California

• United States
• Higher Education
• 700 & Above Employee

• Post Doctoral Research Associate

  • Oct 2010 - Jul 2011

  • Employed to fabricate functional, biotic/abiotic implantable devices used in combination with a commercial prosthesis providing competitive entry into the $94.1 billion market. • Built unique collaborations between the life sciences to produce a reversible, intraocular retinal and cortical prosthesis to be used in systems such as Argus® II. • In vivo and ex vivo testing of prosthesis in rats and rabbits. • Employed to fabricate functional, biotic/abiotic implantable devices used in combination with a commercial prosthesis providing competitive entry into the $94.1 billion market. • Built unique collaborations between the life sciences to produce a reversible, intraocular retinal and cortical prosthesis to be used in systems such as Argus® II. • In vivo and ex vivo testing of prosthesis in rats and rabbits.



UC Center for Environmental Impact of Nanotechnology

• Greater Los Angeles Area

• Post Doctoral Fellow

  • May 2009 - Oct 2010

  • Contracted to investigate nanoparticle protein corona in vivo/vitro for minimizing $1.18 billion cost of risk assessment of toxicity of novel nanomaterials. • Investigated the importance of the protein corona proving a key step for the safe design of nanomaterials leading to completion of three out of seven IRG year one milestones within 6 months. • Instrumental in the development of high content screening and diagnostics for uptake of functional nanoparticles at a maximum screening output of 20,000wells/day. Show less



University of California

• United States
• Higher Education
• 700 & Above Employee

• Gradate Student

  • Jun 2004 - Mar 2009

  Amplified optical detection of protease activity. • Engineered a label-free, in vitro diagnostic for protease activity resulting in 3 manuscripts, a provisional patent, a competitive UC Discovery Grant, and a unique collaboration with Hitachi Chemical Inc. • Refined the ability to design and execute necessary experiments for timely completion of graduate projects and interdisciplinary collaborations • Developed a solid background in chemistry, surface modification, and device fabrication . Show less