Dwight Hanshew

Dwight Hanshew




Quality Systems

Innovating and continuously improving quality systems in both QA and Operational environments is one of the key factors for withstanding FDA scrutiny.  

Teams and Partnerships

Establishing a team approach to leadership, lean manufacturing and continuous improvement; building strategic partnerships, and collaborating successfully with internal and external customers, and contract manufacturers.  

Product Lifecycle

Research and Development; CMC; Submission; Validation; Tech Transfer, Scale-up and Commercialization for generic and brand name pharmaceutical products.  

Mentor and Coach

Mentored and coached individuals in their achievement and promotion to Vice President - Quality Operations and Vice President - Manufacturing Operations at URL Pharma.   Practitioner of "Insigniam Breakthrough Performance"  techniques.  Helping team members achieve success and advancement in the company and the pharmaceutical industry.  

"FDA Correspondence"

Preparing expert FDA correspondence for companies in the United States and around the globe.  

"FDA Inspections"

Sitting across the table from the FDA representing the company...   

Work experience

Work experience
Jul 2012 - Present


DDH Pharma Consulting, LLC

Providing expert advice to the Pharmaceutical Industry in areas of Operations, Quality/Compliance, Manufacturing, Laboratory, Team Building and Leadership by utilizing a unique set of experiences and skills.

Nov 2012 - Present

Senior Associate

Lachman Consulting Services, Inc.

A member of the Lachman Compliance Practice...

While working with a diverse base of companies and providing support for their needs:

  • Performed third-party oversight for single-site and multi-site consent decree remediation
  • Facilitated the vacating of consent decrees involving sterile and non-sterile products
  • Provided expert consultant services for development and execution of numerous remediation/voluntary corrective action plans, which have been accepted by the FDA
  • Provided numerous due diligence activities during the pre-purchase phase for multinational companies and marketing applications
  • Performed numerous highly specialized audits and consultations under attorney-client privilege
  • Performed numerous application integrity audits
  • Facilitated numerous new facility construction reviews for pharmaceutical clients with the FDA
2009 - Jul 2012

Senior Vice President of Pharmaceutical Operations

URL Pharma

While reducing costs by at least 10% year over year on a budget of about US$ 50MM, achieved the corporation’s goals for purchasing, manufacturing, warehousing, distribution, chemistry / manufacturing services, environmental health & safety, engineering & facilities, quality control, quality assurance and compliance activities across three sites in Philadelphia, PA and Chicago, IL using a highly skilled and aligned team of Vice Presidents, Directors and Managers.  This team was empowered with the day to day operation of pharmaceutical operations, which allowed an executive focus on the vision, goals and personnel development of the organization.

2007 - 2009

Senior Vice President of Operations

URL Pharma

Created and coached the company's the first independent high-performing Operations Team composed of Vice-presidents, directors and managers who effectively managed the day to day operations of the purchasing, warehousing, distribution, environmental health and safety, engineering and chemistry and manufacturing services departments using effective, transparent and aligned communication skills.

Nov 2004 - 2007

Vice President of Quality Operations

URL Pharma

Turned around URL Pharma quality and compliance system, via breakthroughs in the Quality Control, Quality Assurance and Quality Compliance Departments.  This resulted in the first-ever "No FDA-483" inspection and was followed by seven consecutive "No FDA-483" inspections.

2003 - Nov 2004

Director of Quality Control

Mylan Pharmaceuticals

While managing the front line of the Quality Control Laboratory, implemented the first measurement of operational metrics program, which communicated the performance of the laboratory publicly to the QC Team.

1998 - 2003

Associate Director of Analytical R&D

Mylan Pharmaceuticals

While holding positions of increasing responsibility in the area of Analytical R&D of Senior Scientist and Associate Director: created, managed and developed important generic and brand pharmaceuticals, such as Levothyroxine Sodium Tablets, Sulfamylon Sterile Powder and Apokyn Sterile Injection serving important medical needs for the patients suffering from hypothyroidism, 2nd/3rd degree burns and Parkinson's freeze syndrome, respectively.

1990 - 1998

Manager of Quality Control

Mylan Pharmaceuticals

While holding positions of increasing analytical and management responsibility in the area of Quality Control from Chemist to Manager made important advances in cleaning validation, blend uniformity analysis, and validated computer programs for calculation of analytical results.


1988 - 1991

Masters of Science

West Virginia University

Eberly College of Arts and Sciences: Master's degree program in Analytical Chemistry (Physical/Organic Electro-chemistry).

"Organized Thiol Monolayers Containing Attached RedOx Centers:  Synthesis, Characterization and Electrochemistry" 1991