Adam Faulkner

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Founder/Owner

PEAK TIMBERCRAFT

Jan 2022 - Current (4 years 7 months)

• Utilizes lean start-up methodology, automation, and just in time manufacture to build and develop CNC and 3D printing company. • Built three V1 Lowrider 3 model CNC routers with iterative design improvements. • Develops digital IP via CAD/CAM and AI. • Performs product research through rapid prototyping and testing using Vectric Vcarve, FreeCAD, Ideamaker, TinkerCAD, EstlCAM, and Cura platforms.

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Senior Quality Control Specialist

Intellia Therapeutics

Jun 2020 - Jan 2022 (1 year 8 months)

• Generated, reviewed, and trended QC data in support of GMP clinical trial product testing in compliance with SOPs. • Coordinated internal and external testing activities including sample management and shipments. • Provided technical expertise including authoring test methods and supporting method validation protocols. ◦ Expedited implementation of Ribogreen RNA quantitation method at CMO to facilitate first GMP manufacturing run. • Authored over 50 raw material specifications to support new product manufacturing. • Managed and tracked QC work orders, purchase orders, and invoices to ensure continuity of testing.

Commercial Quality Control Analyst II

Takeda Pharmaceuticals

Nov 2016 - Jan 2020 (3 years 3 months)

• Served as Subject Matter Expert for Analytical test methods for Biologic and Antibody Drug Conjugate products. • Championed change controls pertaining to commercial test methods filed globally among diverse stakeholders including 6 CMOs and 3 Alliance Partners. • Managed test method validations and qualifications at CMOs. • Oversaw critical reagents and reference standards at external testing labs. • Provided remote troubleshooting and support for commercial test methods for CMOs. • Supported regulatory submissions and resolved questions from regulatory agencies. • Expedited export of reagents and reference standards to support in-country testing of Drug Product globally to ensure critical milestones were met.

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Biochemistry Quality Control Analyst II

SHIRE HUMAN GENETIC THERAPIES

Apr 2011 - Sep 2012 (1 year 6 months)

• Performed UV/vis, Enzyme activity, and DNA Threshold testing for in-process and drug product samples. • Maintained and trended assay and sample data. • Oversaw and trained colleagues in quality control testing. • Authored and executed validation protocols for plate-based enzyme activity testing. • Resolved testing issues, deviations, investigations, and CAPAs.

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HPLC Quality Control Analyst II

LONZA BIOLOGICS, INC.

Jun 2008 - Apr 2011 (2 years 11 months)

• Performed HPLC, bioactivity, and microbiological assays to verify safety, identity, and purity of in process and drug product samples. • Maintained umbilical stem cell lines. • Developed Microsoft Access database to improve real-time tracking and analyses of metrics related to raw materials and chemistry testing and improve productivity and efficiency.

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