Alex Rodriguez

***** ******** *** *******, ** ***36 T : 954-***-**** Email : ad20h0@r.postjobfree.com

EXPERIENCE OPERATION EXECUTIVE

Highly experienced pharmaceutical executive with a strong track record of leading and optimizing operations. Effectively conducted pharmaceutical planning, resourcing, packaging, and manufacturing, providing in-depth research, and prepared reports accurately and timely to resolve complex issues effectively. Adept in major FDA, DEA, EFSA and internal audits. An adroit leader, able to adequately manage the staff of 180+ people. Possess strong decision-making and problem-solving skills needed to identify cost-saving opportunities, lead time compliance, and successfully estimate and implement operation and production plans. Stellar negotiator able to establish rapport with QA/QC, Materials Management, Engineering, and Technical Services as well as collaborating with multiple organization's departments and leading cross-functional teams to develop a trust-based and friendly atmosphere and assure operations quality, compliance, and effectiveness.

Core Skills and Competencies

Pharmaceutical Business Leadership Skills Strategy and Development

Supply Chain Interpersonal Skills Discipline

Regulatory Compliance Team Building Problem Solving Skills

Business Acumen Coaching Skills Conflict Management

Strategic Planning Motivation Risk Management

Communication Delegation Prioritization

BioDuro-Sundia Pharmaceuticals San Diego / Irvine, CA

VICE PRESIDENT AND GM OF THE IRVINE SITE October 2021-September 2023

Lead, develop and coach a Site Leadership team with shared business objectives. Plan and execute site activities consistent with company’s Values, Accountability, Respect, Tenancy, Results, and Integrity. Responsible for the day-to-day leadership, development and management of the development, clinical and commercial operations including R&D, Production, Quality, Supply Chain, Technical Operations, Engineering and Facilities. Manages commercial operations (135 people) through a team of functional executives, managers, and front-line supervisors, and a $48M year Operational Budget. Ensures increasing levels of customer and employee satisfaction while improving the efficiency of manpower, materials, facilities, and equipment.

BioDuro-Sundia Pharmaceuticals San Diego, CA

Sr DIRECTOR MANUFACTURING AND WAREHOUSE January 2020 – October 2021

Responsible for the overall management and oversight of the operations related to the manufacture of spray dry technology, solid, liquid, and semi-solid dosage forms for clinical trial material preparation in support of Phase 0 to Phase II studies for our clients. This position has responsibility and accountability for resource planning and allocation, budgets, financial performance, strategic growth, project management, quality and compliance, customer interface, and manufacturing and warehouse personnel supervision.

UPM Pharmaceuticals Bristol, TN

SENIOR DIRECTOR OF MANUFACTURING AND PACKAGING OPERATIONS 2019-2020

Responsible for managing and supervising the pharmaceutical manufacturing and packaging solid dose and semi-solid operations. Assure that the operation follows GMP's, SOPs, and company policies.

Impax Laboratories Hayward, CA

SENIOR DIRECTOR OF OPERATIONS 2015-2019

Partner with the Site Plant Manager to update on project progress. Coordinate the activities of 203 members in production and packaging for two Oral Solid Dosage Plant. Managed the two-manufacturing site at Hayward, CA, including production, packaging, operational excellence, quality engineering, warehouse, and distribution with a $28M year capital budget.

Impax Laboratories Hayward, CA

DIRECTOR OF MANUFACTURING 2012-2015

Managed production and balance activities at Oral Solid Dosage Plant with one Associate Director of Packaging, four Production Managers, 6 Supervisors, 178 Operators, and a $23M year capital budget.

Alex Rodriguez 954-***-**** Page 2

Established communication with QA/QC, Materials Management, Engineering, and Technical Services and outlined Operational Goals and KPIs to improve future products.

Oversaw the manufacturing of sustained or extended-release and immediate-release products and prepared operational budget estimates increased productivity by 45% by reducing equipment set-up and cleaning times.

Drafted reports for the Vice President of Supply Chain and Manufacturing Operations.

Anchen/Par Pharmaceuticals Irvine, CA

Director of Manufacturing 2006-2012

Carried out the plant start-up, validation, and product launch. Mentored teams on new procedures and reported to the Vice President of Manufacturing Operations and Research and Development. Oversaw new-product transfer activities from Product Development and Validation to Manufacturing and Packaging, as well as CMO and CPO inventory levels, schedule, and product delivery. Optimized equipment and facility resources by implementing cost-reduction projects. Designed and implemented a system able to convey follow-up forecast and inventory position between Corporate Marketing, Sales, and Finance. Accomplished the defined financial goals.

Directed 120 people's operations at two Oral Dosage Plants, namely Commercial Production, Material Management, Logistics, and Engineering Departments, with a $16M year capital budget.

ANDRX Pharmaceuticals Davie, FL

DIRECTOR OF KNOWLEDGE TRANSFER 2004-2006

Drafted regular reports for the Vice President of Pharmaceutical Technology. Coordinated the activities of the department to achieve budget goals and implement cost-reduction projects aimed at maximizing equipment and facility resources. Oversaw audits and coordinated new-product transfer activities from Product Development and Validation to Manufacturing, CMO, and CPO. Assured process optimization by coaching the manufacturing team on new regulations.

ANDRX Pharmaceuticals Davie, FL

DIRECTOR OF MANUFACTURING 2000-2004

Mentored four Production and Packaging Managers and operations of the Production Documentation Department, including batch record issuing, material assignation, and process investigations. Liaised with QA/QC, Materials Management, Engineering, and Technical Services to resolve product issues and reported to the Vice President of Manufacturing Operations. Ensured compliance and prepared budget estimates for manufacturing operations. Designed Manufacturing Standards to improve the accuracy of product requirements.

Supervised the production and packaging processes with 180 people at two Oral Dosage Plants and a $20M year operational budget.

Increased manufacturing reliability 3X (Manufacturing Reliability Team, Cleaning Team, and Set-up Reliability Team) through the Continuous Improvement Teams program.

Reduced inventory write-offs with the First Response Team and R

Root Cause Analysis team's introduction aimed at conducting manufacturing quality investigations along with QA.

PRIOR WORK HISTORY

Production Manager, Andrx Pharmaceuticals 1998-1999

Senior Manufacturing and Packaging Supervisor, Andrx Pharmaceuticals 1997-1997

Senior Production and Packaging Supervisor, Pralex Corporation, St. Croix, USVI 1995-1997

Production Supervisor, Mova Pharmaceuticals, Caguas, PR 1994-1995

Production Supervisor, Schering Plough, Las Piedras, PR 1985-1994

Senior Pharmaceutical Operator, Ayerst-Wyeth Pharmaceuticals, Guayama, PR 1984-1985

Working Section Leader, Baxter Travenol Laboratories, Carolina, PR 1979-1984

Core responsibilities:

Coordinated manufacturing operations and evaluating employee performance. Supervised third-party manufacturing operations and inspected commercial manufacturing equipment for cleanliness and proper functionality. Drafted the production and packaging schedule and conducted product research and process deviations.

Education

Point Loma University, San Diego 08/2020.

Masters in art

Columbia College, Caguas, PR 1996

Bachelor’s degree in business administration

Training Memberships

ISPE San Francisco Chapter

Kepner Treacle Problem Solving and Decision Making Certified

Glatt Fluid Bed Technology

Natoli Tool and Die Maintenance

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