Laura Nicholson Email and Phone Number

Consultant specializing in cGMP operational quality, regulatory preparation and response, start-up, project management and program maturation

This was a continuation of the AD role.

-Managed the site validation team and led the global site validation team that was accountable for all product independent validation/qualification (IQ, OQ, PQ) aspects and cleaning/changeover (PPQ) validation for commercial, Phase 1-3, and pre-clinical phase appropriate validation. -Established VMPs, procedures, policies, and matured validation programs from L0 (build) to L4 (continuous improvement)-Maintained an exceptional regulatory profile with no major regulatory observations for owned workstream-Part of the global cross functional compliance team responsible for the risk register, inspection readiness, and accountable to the Quality Council-Led global validation group for harmonization and change management-Delivered projects on time/on budget for qualification workstreams for a new build of a disposable plant and multiple upgrade/expansion projects-Eliminated deviation, CAPA, and validation maintenance backlogs-Significantly matured the computerized system validation (CSV) and data integrity program including co-designing and completing a 5-year Part 11 remediation project-Compiled SMF, IND, BLA, and APQR annual reports for validation/facility sections and reviewed for other department’s sections-Led cross-functional teams in root cause analysis for complex investigation-Delivered multiple Process Excellence/OPEX projects that resulted in less downtime during production and streamlined the cleaning programs to deliver tens of thousands of savings for each new product introduction-Created eQMS MES solutions for paper-based logbooks and optimized project intake, compliance KPIs, and resource balancing using Microsoft Power BI, Teams Planner, and SharePoint-Facilitated operational strategy risk assessments

-Built site technical program for Hyde CORE cleaning characterization lab start-up including programs for analytical method development/qualification, facility qualification, change management, training, and deviation/CAPA-Assisted with the lab quality program establishment and maintenance-Supported filing and inspections for lab ISO 9001 certification-Supported client audits; no major audit findings for client audits for the lab for owned workstreams-Consulted internationally for pharma/biotech clients in all phases of production for master plans, method and validation programs, SOP creation as well as inspection readiness for FDA/EMA jurisdictions-Successful supported companies dealing with significant regulatory observations and warning letters to successfully navigate response and mitigation-Drafted master plans, SOPs, and facilitated FMEAs for clients-Used VBA scripts to automate data entry and analysis-Developed a subject matter expert development pathway for lab analysts-Created and facilitated a learning group for lab analysts-Assisted in proposals and business development activities

-Process engineering/development technical lead for Amgen’s Prolia/XGEVA products for a CDMO and the Colorado manufacturing facilities and was upstream support for a new fermentation product introduction-Owned product lifecycle including reintroduction readiness, process validation, process monitoring, and risk management-Supported tech transfer of a fermentation product-Successfully compiled and supported annual reporting of statistical process control (SPC) monitoring data for FDA annual reports (APQR)-Supported regulatory inspections in multiple jurisdictions with very low observation rate and with 2 inspections receiving no observations-Championed yield improvement projects which delivered 4% increase in bulk drug substance yield -Supported implementation of Plant Data Warehouse for statistical process monitoring (SPC)-Analyzed data to negotiate appropriate pre-approval change management for a commercial product produced at three manufacturing sites and filed in multiple jurisdictions -Consulted for network sites in cleaning validation program development and issue resolution-Responsible for the process validation program for owned products-Prepared responses, regulatory document sections, and presented in inspections / corporate partner audits including jurisdictions in the FDA, EMEA, Mexico, Japan, Korea, and Australia-Participated in risk assessments for viral and microbial strategies and raw material contamination-Assessed process impact for several complex nonconforming investigations -Lead for process engineering operational excellence-Facilitated a learning group for process engineers across the Amgen network-Performed research for a new drug product formulation technology

-Lead and executed worst case and DOE cleaning characterization studies for technology transfer of products to multiple sites-Co-created cleaning protein degradation method for elimination of product specific assay testing (see awards)-Evaluated method variability and equivalency -Lead operational excellence efforts in cleaning including efforts that delivered 7M in savings in 2 years (see awards)-Co-designed continuous monitoring program for cleaning-Co-chair for Amgen Global 2010 Product & Process Engineering Symposium Poster Committee-Determined the technology and researched protein viscosity for an awarded patent for a novel technique for processing crystallized biomolecules which allowed high concentration proteins to be dosed using auto/self injectors to improve patient compliance

-Led and supported multiple validation and qualification projects -Backup cleaning validation program owner and 21 CFR Part 11 SME-Project lead for equipment and computer qualification projects-Developed S88 requirements for a new plant build in Ireland-Delivered 4 major capital projects for qualification including 2 product reintroductions and 2 new product introductions on time and on budget-Championed and co-championed multiple program initiatives including projects with departmental savings of $143K for 2007 and $284K for 2008 -Created Validation Playbook to align business processes across department and identify gaps-Support for two reintroductions for cleaning which employed use of challenge soilant-Supported regulatory inspections and responses

-Contracted to support a new greenfield plant build. -Supported automation qualification efforts through drafting and execution of requirements documents validation plans, protocols, and summary reports for a new plant-Advised on the creation of key SOPs that governed qualification workflows-Advised on a S88 qualification approach using DeltaV for a new plant in Ireland

-Contracted to support a new greenfield plant build. -Created/executed requirements documents and computer validation documentation for new DeltaV implementation for cell culture bioreactors and chromatography skids-Created equipment validation documentation for a new processing plant-Developed/validated process simulation for offline computer qualification-Assisted commissioning and engineering activities for DeltaV network installation

-Employed 1998-2001 and 2002-2003 (was asked to come back)-Supported client applications buildouts, technical sales and custom algorithm builds. -Created customized process simulations using CAPE products for control system checkout and operator training for the chemical, oil & gas, pulp & paper, and pharmaceutical industries-Interfaced with Foxboro, Honeywell, Siemens, Emerson, Rockwell, and Moore-Apacs control platforms-Developed and co-developed Visual Basic applications for networking-Technical sales and technical support

-Contracted to Roche for a greenfield polypeptide purification plant build -Programmed DeltaV -Developed OQ documentation-Executed IQ documentation