Derek Bailey Email & Phone Number

Fort Collins, Co, Us

• Serve as the single technical point of contact for all chemical raw materials globally• Act with urgency and directness to ensure continued ability to manufacture life-saving therapies• Coordinate, risk assess, and implement change controls for dual sourcing initiatives to de-risk supply chain• Manage and execute change controls for the implementation of new chemical raw materials• Involve regulatory, quality control, quality assurance, procurement, development, and business functions as necessary• Organize cross-functional meetings to lead and drive critical global projects and initiatives• Assess and mitigate risks associated with supplier changes and discontinuations for chemical raw materials• Communicate with stakeholders across the organization to coalesce project plans• Communicate with external billion dollar organizations to mitigate emergencies and ensure continuity of supply• Present to leadership regularly on critical projects, issues, and initiatives• Define strategy for chemical raw material portfolio

Broomfield, Colorado, United States

• Technical SME for all finished products• Extensive cross departmental and extra-organizational collaboration, expectation setting, and project management• Coordinated every aspect of external product development (materials, packaging, timelines, stability, pilots, release)• Worked intimately with Project Management to define deadlines, chase deliverables, and update stakeholders• Performed troubleshooting and improvement of external manufacturing processes• Assisted with packaging identification and mitigation of detrimental stability attributes of packaging• Communicated regularly with executive team on strategy for new products and continuous improvement projects• Participated in internal training of sales staff on technical topics related to MHL products and process• Assisted Operations team in writing protocols for engineering runs, pilot batches, and scale-up activities• Interim Quality Director-generated CoA’s, initiated investigations, reviewed external manufacturing records, and released product• Consulted Operations on purchase and implementation of new lab and manufacturing equipment• Advised on CQA’s for finished goods and assisted in implementation of a system to perform in- process testing• Served as a technical sales resource when appropriate• Managed two direct reports

Broomfield Colorado

• Characterized critical parameters (pH, water content, order of addition, drying characteristics) for pectin gummies• Scaled-up gummy process for use with rapid depositing system• Worked extra hours the develop rapid set pectin gummy systems for multi-billion dollar partner company • Developed tincture, OSD, topical, and nanoemulsion-based products for market• Took new products from bench to full-scale production and developed novel processes• Created batch records, picklists, specifications, SDS’, and other pertinent documentation for new products• Sourced and initiated all new raw materials in company systems• Function as company-wide technical SME on all products• Designed products with GMP-level quality in mind• Worked with marketing, production, analytical development, and quality to ensure all product needs met for release• Met with customers to serve as a technical resource • Trained production staff on new production methods

Greeley Colorado

• Vastly improved and developed first in industry method to accurately quantify liquid deicer performance, never before done• Filed Patent for line of revolutionary deicer technologies• Attended and spoke at several industry conferences on Deicing and winter maintenance• Performed urgent testing to solve customer and sales issues in a rapid manner• Collaborated with academic and government institutions on method transfer/development• Worked with engineers to develop large scale production methods for novel deicing technologies• Ran, maintained, improved, and organized deicing laboratory• Built and improved novel instrumentation for the evaluation of deicers• Spearheaded research into and purchasing of new technology for critical QC testing, reduced runtimes by 85%• Instituted and maintained a controlled laboratory notebook system for all labs• Managed, instructed, and directed college and high school interns

Fort Collins, Colorado Area

• Developed a test to satisfy USP<1> time to gel requirements• Perform storage stability studies on prepared sample and standard solutions• Transfer existing methods to newer instrumentation• Validated new Mettler coulometric Karl Fischer instrument• Assist directly formulating responses to FDA queries• Created a sample tracking system for use by QC and AD• Executed change control records to maintain and update methods, specifications, and pertinent documentation• Organize, tabulate, and report on data for direct inclusion in NDA submissions• Perform supplemental validation work on older methods• Perform R&D and GXP analytical testing

Raleigh-Durham, North Carolina Area

•Perform extraction and determination of Crop application parent and metabolite residues on a variety of matrices•Work closely with Mass spec laboratory and Principal Investigator to process and interpret analytical data•Prepare Residue samples for UPLC-MS/MS analysis•Spearhead critical validation and method development work in close corroboration with Principal Investigator•Design and execute experiments to improve method throughput and functionality•Own and execute analytical responsibilities on specific studies

Raleigh-Durham, North Carolina Area

•Perform testing of in-process materials in support of manufacturing•Utilized HPLC to perform assay and related substance determinations•Perform residual substance determinations on GC•Perform a variety of wet chemistry tests on various stages of in-process product

Durham, North Carolina

•Perform a multitude of different raw materials tests independently •Perform a variety of different instrumental analyses (FTIR, UV, Osmometer, etc.)•5S project lead for reorganization and restructure of laboratory•Test from JP, EP, USP, ACS and in-house methods

(Raleigh-Durham, North Carolina Area)

•Perform a multitude of different raw materials tests independently •Project lead on data sheet creation for entire raw materials testing group•Kan Ban team lead (Re-organizing testing materials, waste disposal system, chemical management)•Test finished product samples when necessary

•Analysis of GMP, Analytical Development, and Formulation Development samples as necessary •Assisted in investigation of aberrant results or OOS data •Performed inspector duties for clinical labeling campaigns, component inspection, and other responsibilities as required•Assisted in writing and revision of SOPs, protocols and reports to describe department activities•Handled and tested schedule 3 controlled substances reliably and without incident

Fort Collins, Colorado Area

•Performed a wide array of raw material, finished product, and stability testing•Utilized HPLC to perform assay and related substance determinations on different sample types•Coordinated out of lab sample testing•Participated in investigational testing•Worked as a member of the Raw materials group

Performed maintenance and alignment on a lab built spectroscopic setup purposed forthe size determination of single stranded DNA • Performed experiments on elucidation of the folding kinetics of RNA and DNA hairpins via fluorescence correlation spectroscopy • Maintained a detailed lab notebook • Made buffers, acid solutions, polymer solutions, and nanomolar DNA/RNA solutions with a requirement of a high degree of cleanliness • Created, converted, and managed a variety of different data file types

B.S, Chemistry

Additional coursework involving relativistic physics, astrophysics. Instrumentation proficiency: UV-Vis, IR, NMR, GC, HPLC, extensive.

Education record