Profile Details

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Hire Robert C.

United States

USD 140 /hr

Quality, Compliance, and Operational Excellence - Consulting for Life Sciences

Profile Summary

Expert skills and industry knowledge to drive superior results in R&D and operations. ✔ Strategic thinker + Tactical problem-solver ✔ Six Sigma Black Belt with deep experience in process design and performance improvement for Quality, Speed, Cost ✔ Creative, pragmatic solutions to increase efficiency, effectiveness, and productivity

Subject Matter Expertise

• ★ Drug Development
• ★ Quality Assurance & Quality Control (QA/QC)
• ★ Six Sigma
• ☆ Chemical Manufacturing
• ☆ Environmental Engineering and Technology
• ☆ Drug Stability Testing
• ☆ Pharmaceutical Manufacturing
• ☆ Small Molecule Manufacturing
• ☆ Clinical Trials
• ☆ Product Evaluation
• ☆ Supply Chain & Logistics
• ☆ Product Design
• ☆ Design for Manufacturing
• ☆ Product Compliance
• ☆ Concept Development
• ☆ Feasibility Studies
• ☆ Gap Analysis
• ☆ Skills Training
• ☆ Technical & Scientific Writing
• ☆ Instructional Materials
• ☆ SOP & Protocol Writing
• ☆ Course Content Writing
• ☆ Nutraceuticals
• ☆ Consumer Products
• ☆ Business Operations
• ☆ Business Strategy
• ☆ Innovation Management
• ☆ Project Management
• ☆ Risk Management
• ☆ Management Consulting

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Feasibility Study, Gap Analysis

Consulting Business Strategy Consulting, Operations Consulting

Data & AI Data Insights

Product Development Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development

Work Experience

Director of Quality Processes and Systems

Hutchmed International

August 2021 - April 2024

Director of Quality Assurance, R&D Solutions

IQVIA

February 2020 - July 2021

Associate Director, Clinical Processes and Training

Acorda Therapeutics

June 2018 - October 2019

Principal Advisor, Biopharma

Freelance Contraccting

March 2016 - May 2018

Associate Director, Process Development; Clinical Quality Management

Eisai Inc.

November 2007 - February 2016

Senior Manager, associate Director - R&D Process Excellence

Johnson & Johnson / Janssen Pharmaceuticals

August 2001 - January 2007

Principal Consultant, Risk Management and Operations Improvement

PwC - PricewaterhouseCoopers LLP

July 1986 - July 1991

Education

MBA

Univ. of Pennsylvania - Wharton School

January 1986 - August 1987

BS

Cornell Univ.

September 1980 - May 1984

Certifications

• Six Sigma Black Belt (6S BB)

  Johnson & Johnson/Janssen Pharmaceuticals

  June 2006 - Present

Publications

PATENT

Robert Chang, Robert Glick, David Rawlings (1987). Mold and Method for Spin Casting a Precisely Configured Article. United States Patent and Trademark Office.