Pharmaceutical Process and Compliance Expert with Proven Track Record in Applying Lean Practices Across Quality Systems and Operations

AREAS OF EXPERTISE

NextGen Biomanufacturing

Process Development Roadmapping and Validation

Technology Transfer

Logistics Planning

Clean Room Strategies and Processes

Application of Lean Principles and Risk Management in Biopharmaceuticals

Facility Validation and Planning

Supply Chain Management

Regulatory and Quality Operations

EXPERIENCE

xCell Strategic Consulting – Principal

IPS – Sr. Advisor/Sr. Consultant (previous Sr. Principal/Board Member)

Strategic BioPharm Consulting, LLC – President/General Manager

ASSOCIATIONS

International Society of Pharmaceutical Engineers (ISPE)

Pharmaceutical Drug Association (PDA)

United States Green Building Council (USGBC)

American Association of Pharmaceutical Scientists (AAPS)

Building Commissioning Association (BCA)

Adjunct Professor, Campbell University Pharmacy Program, 2008-2011

EDUCATION

MBA - Florida International University

B.S., Biology - University of Miami, Florida

B.S., Chemistry - University of Miami, Florida

 

 

Charles Stock, Principal  

Mr. Stock has over 35 years of process/operations and compliance experience in the pharmaceutical, biotech and medical device industries. He has successfully started-up, commissioned and validated cell culture facilities, vaccine facilities, oral solids and liquids facilities, bulk chemical and medical device facilities. His direct experience encompasses facility and system design and qualifications, as well as process validation and process development. His direct operations and compliance experience (owner side) includes start-up and line management in the areas of aseptic processing, blood component processing, in-vitro diagnostics manufacturing, dry powder processing, lyophilization processes, cell culture (small and large scale) and protein processing.

He has recently implemented Lean approaches for engineering and qualification based on current ASTM E2500 and ISPE standards and guides at several branded pharmaceutical companies. He has led several manufacturers in employing Risk Management Practices in decision making related to compliance, product quality, technology transfer and implementation of Lean.

Highlights:

  • Established a Product and Process Development Roadmap with process validation as the goal for an orphan drug designated product at a European biotech development company. Directed the development of a Process Characterization Assessment that resulted in a refined Process Flow Chart with identified CQAs and CPPS that tracks back to R&D data.
  • Developed a logistics planning approach utilizing risk-based methodologies to support the planning, execution and close out activities that spanned equipment qualification to H1N1 product shipment for a leading vaccine manufacturer. As a result, the product was shipped on time and full compliance was maintained.
  • Developed an operational strategy for multi-U.S. site manufacturing for a Novel Cancer Therapy manufacturer that was the first product of this type approved by the FDA. The strategy included the development of a staffing model and reduced expected staffing levels by 35%.
  • Led the initial FDA/EU Gap Assessment for a vaccine sterile filling facility to correct the RABs based facility and filling line issues related to failed PAI. The facility passed PAI and is currently in operation.
  • Directed the development of a Cleaning Process and Validation for a multi-product IVD manufacturer that was done in response to 483 notifications. The project was completed to the satisfaction of the FDA.