Summary
Overview
Work History
Education
Skills
Websites
Languages
Timeline
Generic

ISAIAH VALDEZ

San Diego

Summary

Results-driven executive with a strong track record of enhancing manufacturing efficiency, client satisfaction, and cost savings through comprehensive management of operations, manufacturing, and P&L within fast-paced industries. Experienced in driving revenue growth, optimizing resource utilization, and maintaining high-quality standards while minimizing operational costs.

Key Strengths Include:

  • Operational Leadership & Strategy: Demonstrated ability to develop and implement operational strategies that scale multisite manufacturing processes and drive continuous improvement initiatives.
  • Turnaround & Change Management: Proficient in transforming underperforming areas, promoting a culture of continuous improvement, and negotiating profitable contracts with large corporations.
  • Team Development & Mentorship: Skilled in mentoring cross-functional teams to navigate major challenges, conducting performance reviews, and providing constructive feedback to boost productivity and efficiency.
  • Compliance & Regulatory Adherence: Committed to staying updated with government regulations and industry standards, ensuring all operations remain compliant.
  • Employee Experience & Engagement: Extensive experience in enhancing employee engagement and productivity by standardizing people management practices, developing robust learning and development programs, and building high-performing teams.

Recognized for effectively monitoring daily operations, collaborating with diverse teams, and addressing emerging issues promptly to maintain seamless operations.

Overview

11
11
years of professional experience

Work History

Director, Drug Product Manufacturing

AJINOMOTO BIO-PHARMA SERVICES
San Diego
01.2023 - Current
  • Lead clinical and commercial drug product manufacturing operations, including supply issues resolution, EHS compliance, resource allocation optimization, and regulatory and client audits while ensuring maximum adherence to applicable protocols, regulations, and schedules
  • Oversee manufacturing metrics and site goals, support critical programs, and drive continuous improvement initiatives to meet client and business requirements.

Associate Director, Manufacturing

GILEAD SCIENCES
La Verne
01.2020 - 01.2023
  • Mentored six managers to oversee GMP manufacturing functions including logistics and coordination related to New Product Introductions (NPI) and technology transfer, documentation scheduling, capacity planning, technical support during manufacturing runs, and operational excellence activities.

Senior Manufacturing Manager

GILEAD SCIENCES
La Verne
01.2018 - 01.2020
  • Led four professionals in managing multiple drug product manufacturing and formulation components
  • Reviewed performance of manufacturing managers and team leaders and executed effective plans to improve productivity and efficiency.

Aseptic Manufacturing Manager

GILEAD SCIENCES
La Verne
01.2016 - 01.2018
  • Oversaw manufacturing operations, including managing escalations, implementing process improvements, conducting internal batch record reviews, introducing growth-focused manufacturing procedures, and handling materials while leading a dedicated team of four direct reports.

Aseptic Manufacturing Team Lead

GILEAD SCIENCES
La Verne
01.2014 - 01.2016
  • Directed manufacturing technicians and executed effective plans to enhance their productivity and efficiency
  • Assigned job tasks and provided required assistance to meet manufacturing requirements and achieve cost savings.

Education

Master of Arts in Management -

Azusa Pacific University

Bachelor of Science in Organizational Leadership -

Azusa Pacific University

Skills

  • Strategic Operations Oversight
  • Staffing & Recruiting Initiatives
  • Full Project Life Cycle Management
  • Data Analysis & Reporting
  • Process Redesign/Improvement
  • Good Manufacturing Practices (GMP)
  • Cross-functional Relations Building
  • Full Spectrum of P&L Accountability
  • Staff Training & Development
  • C-Suite Presentation & Reporting
  • Equipment & Facility Maintenance
  • Budgeting & Demand Planning
  • Supply Chain Issue Solutions
  • Regulatory & Legal Compliance
  • Client Experience Management

Languages

English
First Language

Timeline

Director, Drug Product Manufacturing

AJINOMOTO BIO-PHARMA SERVICES
01.2023 - Current

Associate Director, Manufacturing

GILEAD SCIENCES
01.2020 - 01.2023

Senior Manufacturing Manager

GILEAD SCIENCES
01.2018 - 01.2020

Aseptic Manufacturing Manager

GILEAD SCIENCES
01.2016 - 01.2018

Aseptic Manufacturing Team Lead

GILEAD SCIENCES
01.2014 - 01.2016

Master of Arts in Management -

Azusa Pacific University

Bachelor of Science in Organizational Leadership -

Azusa Pacific University
ISAIAH VALDEZ