Edwin Rose Email & Phone Number

Lancaster, Pa, Us

Lancaster, Pennsylvania, United States

Project Manager at GSK

Lancaster, Pennsylvania, United States

Led Logistics team successfully through site closure supporting business needs with reduced staffing while navigating changes in process and transition team from normal production to site closure.-Managed and coordinated dissemination and disposition of raw materials and packaging components to international and domestic sites successfully transferring 23 shipments totaling $1.6M in savings.-Facilitated movement of 1.4M lbs of materials for site closure. Distribution of materials culminated in 87% resite, 12% recycle, and 2% energy reclamation; no materials were sent to landfill.-Spearheaded effort to distribute site Powered Industrial Vehicle (PIV) assets to intercompany sites and liquidate remaining assets. Delivered PIVs to other sites and achieved savings of $60k.-Led and facilitated site area clearance and designed metrics to track progress of building clearance, completed clearance of the site per plan schedule.-Project leader for Imodium Reformulation project including PPQ and associated CAPA. Executed the implementation of reformulation and completion of CAPA deliverables on time.

Malvern, Pennsylvania, United States

Managed the site capital project portfolio CAPEX ($10M+) while partnering with site and offsite stakeholders and sponsors for strategic and tactical portfolio performance. Led the Project Governance process, business case development and approval, project prioritization, and resource assessment. Facilitated the capital project business planning and long-range financial planning. Facilitated monthly Sponsor’s Meetings reviewing capital projects with department management.-Partnered with Finance, Department Leads, and Business Process Excellence team members on project Business Planning and Long-Range Financial Planning (LRFP). -Coordinated generation of 31 business cases through development, review, and approval for site projects; attained Right First Time for all projects.-Coached Project Managers (PMs) from business case generation through project closure by conducting monthly 1-1s with each site PM to review projects, capacity, and resource needs. Efforts realized more effective performance of PMs, stronger collaboration, and improved project results.

Lancaster, Pennsylvania, United States

Led Technical Operations projects focused on cleaning validation and the site Cleaning Validation Monitoring Program (CMP), CAPA, Investigation, Validation Review Committee (VRC), Validation Master Plan (VMP), and Quality Risk Management (QRM).-Completed project using Johnson & Johnson Production System (JJPS) to develop, validate, and implement a new cleaning process for Fette 3090 Tablet Presses. Delivered all objectives including impact to equipment surfaces, ergonomic, steam generation, and Compression Campaign Changeover with total annual savings of $57k.-Completed $500k capital project to purchase, qualify, conduct cleaning validation, and implement Stainless Steel Fill-O-Matics (FOM) in the compression area to simplify cleaning and eliminate equipment dedication due to the previous FORM design.-Order from chaos - Designed, scheduled, and drove project execution of Technical Operations Team in coordinating the manufacturing and compression areas for multiple projects simultaneously. Execution satisfied all project timelines staffing constraints and cost for the Replacement Blender Project, PPQ efforts, and associated Cleaning Validation.-Led site Cleaning Validation Monitoring Program (CMP) program re-design to streamline monitoring documentation from a protocol and report based process to an SOP based format. New program yielded reduced resource requirements while maintaining a robust and compliant monitoring program.

Lancaster, Pennsylvania, United States

Supported Consent Decree goals and objectives by developing new cleaning validation program and executing remediation activities to bring the site to standard. -Cleaning Validation Process Owner for the Lancaster site. Coordinate and partner with peer international site CV work stream to harmonize approaches and activities supporting CD Workplan and Base Business activities. -Maintain coordination with site base business Cleaning Validation team to ensure that integration of CD activities are understood and implemented effectively while minimizing impact to base business activities. -Hire and manage team to execute Cleaning Validation work stream activities. -Led execution of remediation activities to bring the site to standard. Led multiple teams of contractors in execution of cleaning development and cleaning validation of site cleaning process.

Lancaster, Pennsylvania, United States

Led cleaning validation projects and activities including: determination of the VOC, creation/modification of cleaning procedures/processes, change control management, creation and execution of cleaning validation documents, deviation investigation, project team leadership, manage contractors, SOP creation/update, logbook creation/updates, CAPA generation and closure.-Provided technical support for strategic and tactical development of equipment, processes, and cleaning validations as well as new product launches. -Facilitated creation and execution of protocols with management, team leaders, engineers, and quality delivering smoothly executed iterations and validated processes that satisfy customer needs.-Engaged directly with regulatory authorities as site SME for cleaning validation (FDA, MHRA, etc).

Lancaster, Pennsylvania, United States

Supervised manufacture and packaging of liquid products at Lancaster facility. Directed activities for three shift (24 hour) operation producing Mylanta, Mylicon, and Alternagel liquid products. Supervised 21 direct reports including operators and technicians for both manufacturing and packaging areas. Used alternative staffing arrangements to maximize output and reduce overtime while ensuring plan attainment in a resource constrained environment.

Lancaster, Pennsylvania, United States

Plant resource for Package Engineering supporting both Liquids and Solids operations for packaging related projects and compliance resolution. Partnered with marketing supporting Mylanta, Mylicon, Pepcid, and Imodium business projects and line extensions. Supported all aspects of packaging for solids blister, pouch, liquid and solid dose bottling, labeling, and tertiary packaging components. Conducted Packaging Line Trials (PLTs) supporting projects for new packaging components, new products, marketing, and process improvements. Created specifications supporting component introduction and changes.

Demonstrated project management skills while leading and identifying course of action for 13 separate working groups and optimizing their performance. Field operations depended on specific timeline development, coordination between groups, attention to detail plans, and management of logistical support. Led a unit of 120 Marines ensuring all operations and field training activities were properly and safely performed in a timely manner.

Led the fire direction controlmen in the field (8 Marines) and conducted digital field artillery operations at the battalion level. Prepared and submitted reports to the Joint Chiefs of Staff on battalion readiness. Organized and controlled all battalion level professional military education, rifle/pistol ranges, Artillery Firing Area requests, and Gas Chamber Exercises.