- Experience in manufacturing, process, packaging, consulting and construction challenges producing a sharpened authentic Project Manager.
- Expert in project life cycle management performing, effecting and directing projects through initiation, planning, execution, monitoring, controlling and closure.
- Demonstrated collaboration and leadership in strategic initiatives, continuous improvement projects, detail design, construction documents, new product commercialization, technical transfers, validation installation, construction supervision.
- Integrated Lean Six Sigma practices, SPC and KPI throughout physical design and project lifecycle.
- Adhering to design control, authority governance and standard of care promulgated for food, chemical, pharmaceutical, medical device, dental and health & beauty product manufacturing.
- Maintained professionalism in demanding environments working effectively motivating teams drive to successful outcomes during 10 years of manufacturing successes and 15 years of consulting accomplishments. Strong ability to communicate, lead team’s and self - starter.
- Uncompromisingly leverage talent stimulate personnel, champion solution generation boost creative excellence for winning outcomes.
Confidential, West Greenwich, RI
Sr. Project Manager Information Systems / Automation
- Site project manager to strengthen cyber security posture of manufacturing systems. Lead application segmentation and enterprise cybersecurity resilience strategic initiative.
- Manage development and execution strategies for migration of MES, BAS, PI, SCADA, DeltaV, ThinManager, IPMCS, Autoclaves, CU5000, Batch Reporting, LogMate and CDS, LMES, LIMS, Lab Systems to segmented infrastructure and services including: back-up and recovery, change control, documentation updates, IP Address modifications, cabling, update, testing/validation.
- Oversee risk assessment, mitigation, estimates, approval, schedule, cost, quality and resource planning while delivering presentation of site accomplishments to executive leadership.
Confidential, Manchester, MI
Sr. Program Manager
- Work independently managing complex capital projects from conception to qualification acceptance. Oversee stakeholder engagement, productivity, timing, budget, vendors, contractors, qualification. Prepare status reports, assess project issues and develop solutions.
- Analyze and evaluate the performance and cost of new, proposed or existing equipment including machinery, tooling, workflow, reliability, safety, utilities and standard compliance.
- Perfect project implementation, execution plan, elicitation and management of requirements. Communicate Regional Directors, Plant Mangers, Plant Resources, Supply Chain, Marketing.
Confidential, Bloomington, IN
Sr. Project Manager Drug Substance
- Led project teams for the expansion of drug substance including R&D, Engineering, Facilities, Quality Control and functional departments. Oversee bioreactor, harvest, infrastructure, component, equipment evaluation, selection, procurement, acceptance and pilot testing.
- Manage project deliverables including schedule, budget, communication, change management, system impact, validation life cycle, URS, component criticality, commissioning, test matrix, calibration, SOP, spare parts strategy and overall integration.
Principal Packaging Engineer
- Developed cross-functional dynamic global teams with biopharmaceutical clients leading packaging technical transfer, validation, clinical trials, root cause analysis, and commercial launch for combination medical device, secondary packaging, thermoform trays, customized labeling, printed materials, serialization and corrugated packaging of vial and syringe products batches of up to and greater than 100,000 units.
- Provided step-function improvement identifying material and component to increase value flow ceding packaging debottleneck and reduced drug product-controlled storage timeline 62% to ship.
- Identified 30% OEE packaging quick wins resulting in “ready to execute” 75% utilization improvement.
Principal Packaging Project Manager
- Lead $30MM CapEx package material and packaging system improvement; capacity expansion strategic mission to double plant production in 5 years and concurrently deliver reduction in NCR & CAPA by 50%.
- Effectively confined a dysfunctional team and transformed to a cross-functional high-performing unit obviating the project from further schedule delay and cost creep.
- Led global harmonization of raw materials for $67 MM annual saving collaborating with quality, sales, marketing and R&D developing audit and selection program and influence stakeholder prioritization.
- Global technical lead contact for emerging and existing market developed deployment dashboard for simultaneous new products global launch strategic growth initiative of $5 billion in 5 years.
- Identified 20% packaging capacity imbalance averting supply chain forecast deficit.