Frank Ponto

SUMMARY

Corporate professional with well-rounded experience in multiple disciplines including project management, data analysis, and people management.  Proven strengths include: 

·         Project Management

·         Trouble Shooting

·         Risk Management

·         Data Analysis

·         Cross Department Networking

·         Multitasking

·         Metrics/Dashboard Generation

·         SAP/ERP

RECENT ACCOMPLISHMENTS

·         Reduced 6,000 person hours per year for the Document Control department through software improvements. 

·         Optimized processes developed for the Supply Chain to allow for faster vendor audits using streamlined document formats.

·         The successful removal of the warning letter prevented any halt to manufacturing on a $2 billion per year production line. 

·         Beat all of our competitors to market with the first artificial pancreas resulting in a greatly increased market share for insulin pumps.

·         Implemented scalability into the ERP system by implementing SAP. 

PROFESSIONAL EXPERIENCE

Bankers Life Insurance Camarillo, Ca                                                                                     2016-2017

·         Insurance sales (life and health) specializing in Medicare and the senior market

·         Retirement planning focused on preservation of nest egg through financial vehicles

·         Currently licensed insurance agent for the State of California

Medtronic Northridge, Ca                                                                                                       2012-2016

 Oracle Agile PLM Implementation - Project Manager (2015-2016)

·         Assembled team of responsible stakeholders to determine the size and scope of the project.  Developed the Project Charter to identify the scope of the project and identify the key leadership.  Coached the core team in effective project management techniques for them to lead their sub-teams.

·         Developed and maintained the project schedule using MS Project. 

·         Developed and maintained all key documents including the Project Plan, Quality Plan, Risk Management Plan, Testing Plan, Execution/Implementation Plan, and Exit Strategy

·         Led the data team in extracting the necessary data from SAP, scrubbing the data, and importing into Oracle Agile PLM.

·         Identified risks and removed obstacles the project encountered to provide optimal customer satisfaction. 

·         Championed change management and training tools to help the end users prepare for the new system they would be using.

·         Communicated the project status to executive management on a predetermined frequency.

·         Post go-live, ensured that all end users received the support needed to prevent down time in their daily jobs.

FDA Action Improvements - Project Manager (2013-2015)

·         Developed a project schedule to identify and track actions necessary to facilitate timely reporting to the FDA and remediation of Warning Letter items.

·         Assembled documentation for regular reports to the FDA while the Warning Letter was in place.

·         Assembled comprehensive set of data (over 80,000 pages) to have on hand during the follow up inspection.

·         Coordinate the follow up inspection including room preparation, supplies, staffing, meals, and special accommodations

·         Attention to all details resulted in a follow up audit was that lifted the Warning Letter no additional new adverse observations were made. 

Diabetes Pump Project Analyst/Coordinator (2012-2013)

·         Maintain documentation deliverables for phase gate approval meetings

·         Run core team meetings (take meeting minutes and publish to audience)

·         Maintain team web site on SharePoint (includes information stored, website security, and website workflows).

·         Develop team metrics/KPI for communication in monthly status reports.

AMGEN Thousand Oaks, Ca                                                                                                   1992-2012

 SAP Master Data Management and RapidResponse Administration (2008-2012)

·         Created new master data

·         Maintained existing master data and system security

·         Manage department SharePoint web site

·      Mined data and analyzed error reports and key performance indicators using Cognos and Business Intelligence reporting tools.

·      Performed monthly importing of data from SAP into RapidResponse.

·      Supplier vendor management.

·      Forecasting, production planning using SAP and other ERP tools.

SAP Implementation (2006-2008)

·         Project manager for configuration of master data, production data, and transactional data in SAP

·         Project manager for transferring of data from the old system into SAP.

·         Performed data scrubbing, validation testing, and qualified the data transfer.

Production Supervisor (2002- 2006)

·         Monitored and managed daily activities (observe staff, utilities, equipment; identify issues and develop corrective actions; adjust schedule).

·         Maintained compliance with CFRs, cGMPs, SOPs, and safety regulations

·         Participated in over 20 state, federal, and international regulatory inspections

·         Maintained detailed knowledge with all equipment operations and quality programs

·         Ensure proper validation of all production equipment and production processes.  Document validation.

Project manager (1999-2002)

·         Managed all improvement projects for equipment in multiple facilities. Ensured the equipment was always in a good working state ready for use without impacting production schedule. 

·         Identified and procured new equipment.

·         Managed all implementations of new product implementations (includes equipment, process, documentation, validation and staff training).

·         Manage scale up of New Product Introductions (NPI) from research scale to commercial manufacturing size.

Building Engineering (1996-1999)

·         Project manager for the design, constructed, and started up new facility                                                             

·         Designed 32K sq ft facility for the manufacture of multiple clinical products. 

·         This $35M project also required design, development and procurement of equipment. 

·         Wrote all SOPs, validation documents, and training materials

Manufacturing Associate (1993-1996)

·         Performed all aspects of protein purification for commercial and clinical biotech pharmaceuticals. 

·         Performed equipment prep, buffer prep, and operation and maintenance of multiple complex pieces of equipment.

·         Progressed into a lead role which also included scheduling, raw material ordering, and batch record review. 

·         Participate in all validation activities including execution of validation protocols.

Quality Assurance-Microbiology             (1992-1993)

·         Performed liquid particulate testing on final product and completed associated paperwork

·         Performed growth promotion studies on primary and secondary disinfectants which led to approval of more efficient cleaning procedures