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Dwight Hanshew

GLOBAL LEADER IN R&D, OPERATIONS, QUALITY AND REGULATORY COMPLIANCE

Leadership

Transformational leader known for combining scientific expertise with a keen understanding of people, processes, and systems gained from international business experience in the pharmaceutical and allied industries. Trusted advisor to executive, board, and industry leadership on quality systems, lean operations, regulatory compliance, acquisitions, and integrations. Proven strategist with the ability to drive profitable growth in challenging, competitive markets.

Work experience

20152017

Head of Global Research and Development Quality

Mylan NV

Chosen to lead Global R&D Quality Assurance for one of the world’s leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. Directed a team of >80 employees in 18 global locations. Directed clinical and scientific quality program development, strategic planning and program management, and career development and mentoring of local and global team members.

20122014

Vice President, Global Injectable Quality Operations and Compliance

Mylan NV

Selected to run the global quality operations, and compliance integration and remediation activity for the injectable facilities, a $1.75B acquisition with >100 employees in 6 global locations in India, Poland, Ireland, and Brazil. Collaborated with the Injectable franchise commercial and operation teams.

Nov 2012Present

Senior Associate

Lachman Consulting Services, Inc.

Advised clients in the United States and abroad in the areas of Operations, Quality/Compliance, Manufacturing, Laboratory, Team Building, and Leadership. Conducted audits, and prepared responses and correspondence to FDA. Provided coaching to firm’s management regarding interaction with Health Authorities.

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
2009Jul 2012

Senior Vice President of Pharmaceutical Operations

URL Pharma

Directed the corporation’s purchasing, manufacturing, warehousing, distribution, chemistry and manufacturing services, environmental health and safety, engineering and facilities, quality control, quality assurance and compliance activities. Managed $50M budget with a team of 300 – 500 direct and indirect reports across 3 sites in Philadelphia and Chicago. Traveled internationally and negotiated global supply agreements to ensure consistent and steady supply chains including back up plans in the event of regulatory difficulties or natural disasters.

20072009

Senior Vice President of Operations

URL Pharma

Directed purchasing, warehousing, distribution, environmental health and safety, engineering and chemistry, and manufacturing services. Created the Chemistry and Manufacturing Services, a team of formulators, analytical scientists and pharmaceutical process engineers, to build a robust continuum between R&D and commercial operations.

 

Nov 20042007

Vice President of Quality Operations

URL Pharma

Recruited by URL Pharma to remediate and revolutionize the Quality Control, Quality Assurance and Quality Compliance programs. Developed and implemented the company’s first employee awareness program called “Quality First – Always.

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.

2003Nov 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.

19982003

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.

19901998

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.

Skills

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...   

Education

19881991

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

United States Patents

Storage Stable Thyroxine Active Drug Formulations and Methods for their Production

7,195,779

7,052,717

6,936,274

6,645,526

M&A Experience

Skills (at a glance)

Dwight's Linked In

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Key Accomplishments

Key member of executive team that transitioned URL from generic to brand pharmaceuticals. Company needed to reorganize and implement state of the art, premier quality systems to become a specialty pharmaceutical company.Part of the Team to turn the company into an attractive acquisition for sale to Takeda USA.

Sourced and built redundant supply chain for company’s number one Brand, Colcrys®. Traveled internationally and negotiated global supply agreements to ensure consistent and steady supply chain including back up plans in the event of natural disasters. 

Instrumental in acquiring FluidAir Pharm Pro. URL Pharma lacked appropriate development and commercial scale capabilities for fluid-bed manufacturing. Led advance team in acquisition of facility (US$8M deal) and oversaw integration. Implemented a program for multi-site production and critical commercial business redundancy achieving site approved for commercial production of Colcrys®.

Sped up launch and scale-up time for new products. Developed a team approach to product transfer and product improvement at URL Pharma. Implemented metrics to create transparency, accountability and improve work standards and operational excellence via the chemistry and manufacturing services department (CMS). Extracted non-core competencies from R&D, production and laboratories to develop team approach to product transfer and product improvement.

Enhanced quality / reduced costs by US$1.7M with continuous process improvements.

Transformed the technology transfer process to achieve robust and repeatable results. Created the team of chemistry and manufacturing services  (CMS) and pharmaceutical process engineering (PPE) to capture and record the institutional knowledge of products and processes. CMS and PPE performed long-term statistical analysis to evaluate product improvement opportunities ensuring a continuum between R&D and commercial operations.

Created a Pharmaceutical Process Engineering (PPE) Program.  As part of the CMS program, process engineering was implemented to capture institutional process knowledge and monitor the ongoing performance of manufacturing products and processes.

Initiated new Environmental Health and Safety program.  Hired the subject matter expert and implemented an enhanced program to raise awareness and compliance levels with local, state and federal programs.

Revolutionized the Quality Systems of URL Pharma. The company was struggling with quality issues including multiple recalls and multiple product discontinuations.  Modernized cGMPs (Good Manufacturing Practices) and implemented state of the art quality practices and electronic systems.  Received 24 FDA approvals and led 15 of those to launch.

Achieved first “no 483 inspection” result ever for company,  andfollowed-up with seven consecutive “no 483 inspections”.

Developed and implemented the company’s first employee awareness program called “Quality First – Always.” 

Lead Analytical R&D Scientist of the CMC and packaging of Sulfamylon®, a unique drug product used in the treatment of serious burns sterilized by gamma-irradiation.

Lead Analytical R&D Scientist of the formulation, CMC, packaging and delivery device of Apokyn®, a sterile injectable drug product used in the treatment of Parkinson’s Freeze.  The product utilized a cartridge vial and pen injector. Collaborated with domestic and international contract manufacturers to ensure high quality, efficient production with appropriate costs.

Received four patents for the development, improvement of stability and uniformity for Mylan’s premier generic formulation of levothyroxine sodium tablets enabling Mylan to enter into one of the largest prescription drug markets in the Unites States.

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