Experience

HUVEPHARMA, INC

• United States
• Veterinary Services
• 100 - 200 Employee

• Senior Director of GMP Operations

  • Apr 2020 - Present

  Huvepharma is a fast-growing, global pharmaceutical company with a focus on developing, manufacturing and marketing human and animal health and nutrition products. Reporting to the North America President, recruited to lead multi-sites manufacturing operations in North America including the operations strategic direction and long-range capacity management for 50+ new products portfolio. Established a robust organizational effectiveness structure to manage products supply, new products introduction, and inspection readiness for the NA muti-sites operations. Accountable of the strategic oversight including Manufacturing, Supply Chain Planning, Engineering, Quality Operations, Process Technology and EH&S. Accountable for operations performance, business continuity plans as well as the preparedness for regulatory inspections (FDA, PHARM- Board, HACCP, USDA)



Cambrex

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• General Manager

  • Jun 2022 - Mar 2023

  Reporting to the Business Unit President, lead and direct business strategies to achieve profitability and business objectives in a CDMO environment. Member of the DP BU leadership team and Lead member of the Site Leadership Team provides leadership, mentoring, and guidance to transform the E2E operations and achieve overall site objectives which includes full accountability for the P&L. Reporting to the Business Unit President, lead and direct business strategies to achieve profitability and business objectives in a CDMO environment. Member of the DP BU leadership team and Lead member of the Site Leadership Team provides leadership, mentoring, and guidance to transform the E2E operations and achieve overall site objectives which includes full accountability for the P&L.



Pfizer Meridian Medical Technologies Inc.,

• St. Louis MO

• Business Consultant / Quality System Remediation

  • Feb 2019 - Apr 2020

  Meridian Medical Technologies Inc. is a subsidiary of Pfizer that manufactures sterile drug-device combination antidotes (auto-injectables) against critical, time-sensitive, life-or-death situations distributed in more than 30 nations around the world. Led the remediation of the Vendor Quality Management Systems under FDA Warning Letter which includes the Purchasing Controls workstream as part of the workplan. Established a robust risk management plan to remediate the Vendor Quality Management System (VQM) and achieved inspection readiness for the vendor management program with zero (0) critical observations in three (3) regulatory inspections (FDA, TGA and Canada Health Authority).



Nesher Pharmaceuticals (USA) LLC

• United States
• Research Services
• 1 - 100 Employee

• VP General Manager / VP Operations

  • Sep 2016 - Nov 2018

  Nesher is owned by Zydus Cadila, is a global healthcare provider and one of the top five pharma companies in India, with 12,000+ employees and $1.8B annual revenue. Zydus operations in Europe, Latin America and the US. Reporting to NA CEO. Assumed the leadership of a startup operation with several products under consent decree. Thrusted the expansion, development and launch of new products under severe regulatory scrutiny achieving compliance for external audits and inspections. Directed a senior staff of 10 reports in Operations, EHS, Technical Services & Technical Services, Engineering, Procurement, Operational Excellence & Continuous Improvements, Supply Chain, Procurement, Warehouse and Logistics in a matrix organization with ethnical and cultural diversity. - Managed and directed as senior leader the compliance state of control and operational performance of two oral solid dosage sites applying best practices and Lean initiatives. - Co-chaired the Quality Council, active member of Sales and Operations Governance and served as Liaison for Community and Government Affairs. - Managed / oversaw Quality Operations, Regulatory Affairs, Finance, IT and HR. - Led the strategy execution, business performance, products supply for controlled substance and critical generic drugs with positive impact to P&L.



McNeil Healthcare, LLC

• Las Piedras PR

• Senior Director Operations (2014 – 2016)

  • Mar 2014 - Sep 2016

  McNeil Consumer Healthcare is an OTC drugs and consumer products manufacturer - division of Johnson & Johnson. McNeil markets well-known and trusted OTC products including: Tylenol, Sudafed PE, Motrin, Benadryl & Imodium. Directed the large-scale operation, # 1 Global J&J OTC, solid dosage manufacturing sites, with $121M in cost of production. Led a senior staff of 11 direct reports in the areas: Engineering, Maintenance, Systems Engineering, Manufacturing, Packaging, Operations Quality and Operational Excellence – Process Improvements under FDA Consent Decree status. Expanded role to direct Supply Chain, Procurement, Distribution and Logistics including PMO. •Drove strategic plans in compliance with FDA Consent Decree, with the challenge of expediting transformation, adapting culture and creating a cost-effective, high-performance organization with zero FDA/ third-party observations and timely closing on all work plan steps. •Spearheaded multiples organizational transformation projects using collaboration, tact and diplomacy within strong change management process; integrated models to optimize competencies and strengthen synergies and structures across each area. •Led as Global Process Owner for Manufacturing Controls Standards and Procedures holding management and staff accountable for maintaining high production quality. •Defended the Site State of Control Plan to Sr. Leadership, external consultants and the FDA. •Active member of the Quality Council and Delegate of the Executive Quality Council.



Merck & Company

• Las Piedras, P.R.

• Supply Chain Director / Project Management Office Director

  • Feb 2011 - Mar 2014

  Merck ( Revenue in excess of $42B) is a pharmaceutical giant's whose top products include diabetes drugs Januvia and Janumet, cancer drug Keytruda, HPV vaccine Gardasil, cholesterol combatants Vytorin and Zetia, and hypertension fighters Cozaar and Hyzaar. In 2017, Keytruda was the first cancer drug based on tumor genetics to be approved by the FDA; it has been approved for metastatic lung cancer and for several other indications. Managed and led Global Harmonization Strategies: Quality, Planning, Materials Management, Clinical Products and Pharmaceutical Commercialization Technology. Previously directed Planning Operations for oral solid dosage products, distributed to domestic / international markets including clinical and new products introduction. •Implemented the Program Management Office for multi-sites in the Puerto Rico Operations; ensured efficiency and profitability KPIs in all lifecycle projects: Capital, Improvements, Cost Structure, Compliance, and Operations. •Instituted a Project Management Office (PMO) to manage the strategy realization for the Puerto Rico’s Pharmaceutical Organization. •Led many key projects: Master Plan Process, ERP Readiness, Commercialization Model Business Process Streamlining, Knowledge Management Strategy, New Products Introductions, Benchmark Data Gathering, Legal Entity Integration and Inventory Management Business Process, and piloted multiple initiatives.



Schering Plough / Merck & Company

• Las Piedras, P.R.

• Senior Manufacturing Manager

  • Sep 2005 - Feb 2011

  Led Large-Scale oral solid dosage manufacturing operations with an assigned multi-million-dollar budget. Ensured compliance with regulatory commitments under the Consent Decree. •Transformed and fostered an engagement culture, measurable by KPIs, strategic alignment and innovation that yielded improvements in productivity, efficiency and quality. •Supervised 12 direct reports: manufacturing supervisors, engineers, and administrative staff •Closed Consent Decree compliance commitments with FDA one year in advance; drove MPS Operational Excellence methodology in operations. •Led the World Class Accreditation for Production Planning Inventory Control. •Re-structured the organizational model to Integrated Production Team.



Watson Laboratories

• Humacao, P.R.

• Manufacturing Manager

  • 2003 - 2005

  Managed and directed a fast paced oral solid dosage manufacturing operations with five direct reports. Responsible for the E2E activities of the value streams related to pharmacy, blending, granulation, compressing, encapsulation, and coating as well as safety, regulatory compliance, environmental programs and continuous improvement programs. Managed and directed a fast paced oral solid dosage manufacturing operations with five direct reports. Responsible for the E2E activities of the value streams related to pharmacy, blending, granulation, compressing, encapsulation, and coating as well as safety, regulatory compliance, environmental programs and continuous improvement programs.



Guidant

• Dorado, P.R.

• Senior Manufacturing Supervisor

  • 2000 - 2003

  Led 75 direct reports toward a team strategy environment, successfully increasing production volumes and key business indicators in an electronic documentation certified business. Investigated process deviations and implemented corrective actions. Directed transition to deliver a 300% increase in production demand. Collaborated in new product process validation, problem solving and process deviations. Implemented SOP's and Policies. Implemented a Kanban Inventory Pull System that resulted in 30% inventory reduction.



Wyeth Pharmaceutical

• Guayama, P.R.

• Manufacturing Supervisor

  • 1991 - 2000

  Supervised the OSD operations in compressing, weighing, coating, inspection, granulation, printing and weight sorting of tablets and capsules including controlled substances. Acting Manager on numerous occasions. Collaborated in new product validation processes, problem solving and process deviations. Implemented SOP's and Policies. Responsible for budget expenses and labor utilization by ensuring continuous improvement and regulatory compliance. Maintained SOP’s updated revisions including on time completions of process deviations, CAPA’s and Change Controls.