Matthew Loucks Email & Phone Number

Raleigh-Durham-Chapel Hill Area

Evaluates development studies for clinical and phase 3 ophthalmic products. Executes method transfers for phase 3 and commercial ophthalmic products. Author regulatory documents including development and transfer protocols and reports for clinical, phase 3 and commercial studies.

High Point, North Carolina, United States

• Supervised team of scientists executing analytical method validations supporting customer soft gelatin formulations.• Managed the stability of customer and in-house projects/products by scheduling weekly laboratory activities.• Successfully transferred product/cleaning validations from development to commercial laboratories.• Mentored and provided technical support to junior scientists on validation practices, site and departmental guidelines, and laboratory instrumentation.• Established and maintained collaborative relationships when coordinating, implementing, and driving new and transferred projects and activities with customers and colleagues.• Ensured on-time delivery, right first-time, and change management by utilizing Trackwise application, in concert with Root Cause training, to perform GMP assessments.• Skilled in technical writing by authoring, reviewing, and approving regulatory documents including new and revised test procedures, specifications, validation protocols and reports following regulatory and industry (ICH) guidelines.• Led and participated in 5S activities to reduce laboratory waste.

High Point, North Carolina, United States

• Developed and executed analytical method validations to support customer soft gelatin formulations using U/HPLC, LC/MS, GC, Dissolution and Particle Size technologies.• Exceeded customer satisfaction by developing and analyzing pharmaceutical products for safety, quality, identity, potency, and purity using attributable, legible, contemporaneous, original, and accurate documentation ensuring data integrity.• Participated in site Branding team to drive Global goal of representation in company communications and assets.

High Point, Nc

● Contracted (at Thermo Fisher Scientific) to develop and execute analytical method validation activities encompassing soft gelatin capsule formulations using UHPLC’s, GC’s, Dissolution and Particle Size.

High Point, North Carolina

● Developed and executed validation activities for soft gelatin technologies using UHPLC’s, GC’s, Dissolution and Particle Size.● Increased company throughput and reduced run time of 86% by redevelopment for mainstream multi active product.● Expanded company portfolio by successfully developing methodologies for opioid soft gelatin formulations, including IVIVR procedures mimicking successful clinical data for several formulations.● Authored new and revised test procedures, specifications, validation protocols and reports.● Implemented Empower 3 computer data system, including blueprinting, gap analysis, configuration, testing, training and go-live support.● Optimized laboratory performance by maintaining Empower equipment connectivity, folder structure and organization, with continuous support and maintenance.● Served as Empower local administrator.

High Point, North Carolina

● Developed and performed validation activities for soft gelatin technologies using UHPLC’s, GC’s, Dissolution and Particle Size. ● Implemented continuous improvement strategies (5S) that optimized team performance and laboratory efficiency by identifying process problems / concerns and resolving issues.● Attended Pittcon and AAPS events representing Banner Life Sciences, using functional / technical poster presentations, as a highly regarded CMO for validation activities.● Mentored junior colleagues on procedures, laboratory guidelines and instrumentation.● Served as Atlas local administrator

Wilson, North Carolina

Performed generic pharmaceutical analytical testing for customer specific products. Participated in 5S activities and led quality system enhancement team to improve documentation practices.● Conducted specific Assay, CU, Related Compound, and Dissolution determinations, including USP / Compendial Testing, for finished goods utilizing HPLC, GC, Dissolution, and UV / VIS techniques.● Led quality system enhancement and implementation team as mentor for document revisions, which established best suited practices for laboratory worksheets, training guidelines, and SOP structure and content. Trained colleagues utilizing new formats and writing techniques, as well as, analytical instrumentation and analysis.● Exceeded customer satisfaction by analyzing generic pharmaceutical products for safety, quality, identity, potency and purity to ensure on time deliveries and right first-time analyses using data integrity policies.● Utilized Laboratory Information Management System (Labware LIMS) software for result entry and data trending.

Forest, Virginia

Performed Method Improvement / Validations following ICH guidelines during Remediation efforts.● Reclaimed company integrity by remediating filed product documentation during gap analysis.● Ensured on time delivery and right first time by assisting with management responsibilities.● Subject Matter Expert for the GC and Particle Size (Malvern 2000) instrumentation and analysis.● Utilized Laboratory Information Management System (SQL and Labware LIMS) software for solution preparations, result entry and data trending.

Forest, Virginia, United States

Participated in global initiative to integrate Raw Materials (API and Excipients) into site with collaborative teamwork between subsidiary facilities.● Ensured on time delivery and right first time by assisting with management responsibilities.● Subject Matter Expert for the GC and Particle Size (Malvern 2000) instrumentation and analysis.● Utilized Laboratory Information Management System (SQL and Labware LIMS) software for solution preparations, result entry and data trending.

Forest, Virginia, United States

Completed thorough examinations of LIMS, and colleague’s notebooks for accurate and proper testing procedures and analysis according to current SOP’s and USP.Performed specific analytical testing, including USP / Compendial testing, for finished goods Assay, CU, Related Compound, Dissolution, and Raw Materials utilizing HPLC, GC, Dissolution and wet chemistry techniques.

Forest, Virginia, United States

Completed thorough examinations of LIMS, and colleague’s notebooks for accurate and proper testing procedures and analysis according to current SOP’s and USP.Performed specific analytical testing, including USP / Compendial testing, for finished goods Assay, CU, Related Compound, Dissolution, and Raw Materials utilizing HPLC, GC, Dissolution and wet chemistry techniques.

Cedarburg, Wisconsin

Performed routine and non-routine product analyses to raise diverse CMO stature.● Performed specific in process analytical testing for Assay and Related Compounds, including USP / Compendial testing utilizing HPLC, GC, RotoVap, UV / Vis and wet chemistry techniques.

Midland, Michigan

Performed startup and routine product analyses to achieve diverse CMO position.● Performed specific in process and finished goods analytical testing for Assay and Related Compounds, including USP / Compendial testing using HPLC, UV / VIS, polarimetry, and wet chemistry techniques.● Executed bulk solvent purity determinations by GC.● Performed IQ / OQ / PQ on HPLC systems.