Responsible for multiple sub-projects associated with the implementation of the Tech Ops network strategy.

Responsible for the downstream Purification operation at Shire's Lexington Technology Park. Scope of responsibility includes both commercial and clinical operations as well as support of Tech Transfer initiatives and continuous improvement.

Member of the National Alumni Council (NAC) at Bryant University in Smithfield, RI.

Responsible for Mfg Technical Services at Novartis' Emeryville CA location.Scope of responsibility includes logistics and preparation of materials and intermediates used in the manufacture of 20+ antigens used for diagnostic blood screening kits.

Led a high performing team of manufacturing staff producing the bulk drug substance Enbrel. Scope of responsibility within downstream operations included large-scale Purification processes as well as preparation of buffers and production equipment.Experience with large scale Protein A and ion exchange chromatography, as well as tangential flow filtration.Managed daily schedule and task assignments to ensure adherence to scheduled operations.Managed direct report work load and project assignments to support high level plant initiatives.Trained and developed new manufacturing staff in the areas of process automation, equipment set-up and break down, and revision of standard operating procedures.Trained and developed existing manufacturing staff to utilize a fully integrated ERP system and electronic batch records.Supported high level non-conformance investigations including product impact analysis.Participated in the team effort to increase production run rate from 7 days to 2 days.Participated in the team effort to advance the maturity level of quality systems within manufacturing as compared with the rest of the industry.Completed high level value stream mapping team activities to identify and implement process improvementsAnswered direct questions from FDA auditors during recent inspections and assisted with follow-up responses. Engaged manufacturing floor staff to participate in the plant inspection readiness program.Managed a department Performance Board (Balanced Scorecard) to track key performance indicators.Trained in lean manufacturing techniques and methodologies.Currently owning/leading a daily tactical meeting for coordinating information between manufacturing managers and cross functional stakeholders.Recently completed training in the area of building and leading high performing teams.

Led a team of manufacturing staff through a new facility start-up. Scope of responsibility included large scale Cell Culture, Media preparation and Equipment Preparation. Achievements included commissioning of new equipment and completion of clinical followed by commercial product runs. Experience with large and small scale cell culture bioreactors, continuous-run centrifugation, and product harvest technologies.Experienced at working off shifts including 3rd or graveyard shifts.Partnered with Quality Assurance to complete timely documentation review and reduce non-conformances.Led department wide initiative to develop and implement a training plan for concurrent new product introductions.Developed and owned the Cell Culture department communication plan consisting of all planned communications forums and frequencies for the department.Successfully integrated new department staff members. Increased to a total of eight direct reports.

Led inter-departmental team working on a New Product Introduction training project responsible for the development and delivery of new high level training materials.Participated in the team effort to implement the global Basic Skills for Manufacturing course. Delivered training sessions at multiple operations sites in the USA and Puerto Rico.Provided training support to manufacturing and plant engineering groups. Responsibilities included delivery of task based on-the-job training, performance consulting, and assistance with FDA inspections.Conducted periodic training audits of client organizations to ensure compliance with applicable regulations.

Participated in team effort responsible for large-scale fermentation operations.Performed operations including equipment set-up, vessel inoculation, CIP, SIP, and LAF Hood aseptic operations.Promoted to Sr. Associate in 2002 and assigned duties for lead associate on Weekday Graveyard shift. Participated in cross-training initiative resulting in proficiency on large-scale protein purification operations.Conducted daily real time on-the-floor document review of both SOPs and MPs.Periodically reviewed and revised applicable documents to ensure safety and compliance.

Participated in the team effort responsible for daily batching and transfer of production and growth type media for large-scale Cell Culture bioreactors.Assisted with bioreactor operations including sterile additions, monitoring, and maintenance.BUSINESS / COMPUTER SKILLS:Microsoft Word, Excel, PowerPoint, Large Group Classroom Training, On-the-Job Training, Needs Assessment and Analysis, Curriculum Design, Project Tracking and Evaluation, Strategic Analysis and Decision Making, SWOT Analysis, Organizational Behavior Analysis, Lean Manufacturing, Internal Business Consulting