Douglas H. Clark    cGMP Brief Technical Experience Overview:

SUMMARY:

Goal-oriented, Quality & Manufacturing/industrial leader with hands-on experience and customer satisfaction, and budget for private companies and Fortune 500 companies that includes 3rd party cGMP contract manufacturing experience.

AREAS OF EXPERTISE/CORE COMPETENCIES:

ISO 9001:2015/ISO 14001 Regulatory/FDA Inspections Culture Improvement/Staffing

ERP Systems/$350MM Projects  Entrepreneurial Spirit  Packaging/Labeling/Cold Chain

Internal/External Outsourcing Single-Use/Medical Device Customer Centric Approach.

Green Belt 6 Sigma, Villanova Continuous Improvement Agent of Change/Audits

Lean Manufacturing/CMO Just-in-Time Production  Cost Reduction/Avoidance

SPC Monitoring/ISO 13485 Optimizing Processes  ‘Can-Do’ Mentality/KPIs

ISO IATF-16949 Certified  Apheresis Blood Products Supply Chain/P&IDs

● Successfully led high profile 24/7/365-day operations for cross-functional quality/manufacturing teams and provided strong management skills to ensure that key risks and opportunities were identified, captured, and presented in an unbiased way. Strong management expertise with a diverse background investing in people and coaching and developing staff (AQS Solutions, ISO 9001:2015/ISO 14001:2015 Integrated Auditor Training). 

● Drug products/products: OP-1 medical device, FDA licensed Insulin, cell culture-based products, First-of-Its Kind immunotheraypy new cGMP facility startup experience, Small/large scale bioreactor startups, ISO 7&8 cleanroom experience, silicone injection molding, drug packaging, and single-use technology, and cGMP bioreactor plant startups. 21 CFR Part 210, 211, 820 and IATF 16949 certified.

ISO/QMS implementation for a cGMP plant site based on VOC (Voice of Customer).  Achieving ISO 9001:2015 certification resulted in increase customer base.  An increase in sales and positive impact on the business operations resulted.

Responsible for Leading a team of direct and indirect quality functions with accountability for the Medical Device Franchises Quality Assurance and Compliance programs goals. Accountable to ensure all products are designed and produced to meet specifications, regulatory body, and company standards. Support Business unit management to meet their division objectives through the franchise quality goals. Represents the Corporate Quality voice in any Franchise leadership strategy meetings, manufacturing plant reviews, multi-functional meetings related to Medical Devices, and design projects. In alignment with the Corporate Compliance team, manage the franchises compliance program required portions of cGMP (QSR) 210/211/820, Medical Device Regulation (MDR), Canadian Medical Device Directive, CFDA, PMDA and other agencies. In alignment with the Corporate Quality Systems team, manage and drive QMS compliance remediation as necessary. Oversee the franchise QA metrics (KPIs) to track Quality initiatives and effect overall improvements QMS activity. 

Performed gap assessment of cGMP manufacturing equipment and production plant based on business and compliance drivers.  Discoveries included a lack of PQ Performance Qualification data.  I led a team of cross-functional leaders and we presented a case to senior management resulting in agreement to invest over $105,000 in validation enhancements.  

Key member of corporate due diligence technology acquisition teams.

Skid based systems: Automated and manual bioreator skids, military skids, and (CIP) Clean-In-Places skid based systems.  Diaphragm valves, pumps, fittings, valves, and Swagelok fittings. Experience with: Specialty hoses, including Flexline stainless steel hoses, and Monel high purity  welded custom high purity assemblies. 

Responsibility includes assessing possible technology and CMOs to partner with.  I successfully obtained senior management buy in to re certify the current clean room to ISO 7 standards versus previous ISO 8 standards.   This upgrade was based on VOC Voice of Customer and understanding of current customer marketplace. The investment for the recertification cost was exceeded by new customer growth and sales after 6 months.   

• Developed and implemented operating policies and procedures across  multiple departments, continuously evaluating for improvements to  maximize growth and efficiencies.
• Responsible for technical oversight of CMO.
• Responsible for internal batch record review, product release and batch trend analysis working closely with PD and other technical leadership departments.
• Responsible for the logistics, shipping and supply chain management.
• Identified other supply partners for the Company’s products.
• Worked with technical leadership and Quality to enhance the Quality Management System.
• Managed the relationship with suppliers to ensure manufacturing  continuity while maintaining adequate inventory levels and on-time  shipping, identification, oversight and management of CMOs.

Team member for a startup and cGMP efforts for a newly constructed multi-million-dollar immunotherapy clean room cGMP plant.  This facility was the first cellular immunotherapy facility approved by the FDA in the US for this type of manufacturing. 

Immunotherapy new plant startup- My team delivered the first phase of a project on time and online in 14 months.  This included all construction, procedures development, PM’s Preventive Maintenance programs in place, hiring and training department staff, PAI Preapproval Inspection responsibilities resulting in a successful FDA Inspection (zero 483’s for my areas of responsibility).  Led multi-million dollar building service contracts for large cGMP FDA approved Clean Room Facility.  

Operational Excellence - Lean (Green Belt) Six Sigma certified formal experience that helps to lean out processes, save time, cut redundancy and waste in order to increase efficiency and profits. (5Y, 8D, FMEA and other Risk Assessments, Process Flow Mapping, and Kanban methodologies. 

Strategic planning and leadership experience dedicated to growing CMO services that provided superior cGMP services and first-class customer service.  Contract Manufacturing -   experience includes: cGMP Class 100; Class 10,000; and Class 100,000 clean room manufacturing; microbiology testing labs; characterization services; media; buffer; microsphere manufacturing, bioreactor services; purification services; filling and labeling; services.  

Manufacturing and laboratory facility (BOD) Basis of Design experience.  Contract Manufacturing -   experience includes: cGMP Class 100; Class 10,000; and Class 100,000 clean room manufacturing; microbiology testing labs; characterization services; media; buffer; microsphere manufacturing, bioreactor services; purification services; filling and labeling; services.  

Capital Projects - Laboratory capital expansion projects, equipment selection, IQ, OQ, PQ validation support, facility, facility systems commissioning and maintenance set ups.  Manufacturing and laboratory facility (BOD) Basis of Design experience.  

Operations - Operations and Development experience encompassing: FDA commercial FDA approved drugs - OP-1 Med Device, tPA, PROVENGE.  Vial thawing and initial culture, T-flasks, roller bottles, shaker flasks, cell bags, single-use bioreactors, single/double use sterile tubing assemblies, silicone molded and over molded sterile assemblies, hollow fiber bioreactors, ceramic core bioreactors, high density perfused cultures, (pioneered by Verax microcarrier fluidized-bed bioreactors”), large scale SS perfusion and stirred bioreactors, media preparation; buffer and reagent preparations, clarification (MF/UF, centrifuge, depth filtration), chromatography, lyophilization, and bulk aseptic filling.  

Process Development/Technology Transfer - Cell culture and bioreactor optimization studies in order to adapt media formulation, buffers, and reagents to the cell line to achieve the highest product yield.  Cell Cryogenics - controlled rate freezing/master cell banking, storage and maintenance.  Operations Support Systems - CO2 incubators, Microscopes, centrifuges, autoclaves, depyrogenation ovens, Gamma sterilization, parts washers, Biosafety Cabinets, filter integrity testers, freezers, refrigerators, warehousing support, Compendial Water Systems, Clean Steam, CIP/SIP systems (large scale), critical gas systems, process control systems, HVAC, Classified Environments, and Building Management Systems.  

Compliance/Regulatory/Quality - (BLA preparation, 510 (k), state and local permitting, FDA and EU compliant facility operation and design, SOP development, training and cGMP based Quality Systems.  ISO 13485, ISO 9001:2015 Quality Management, Quality Manual Management, Quality Systems Management, Pre-Approval Inspection, and FDA Inspections that includes commercial drug experience.  Hosted/led over 150+ different types of inspections in 30+ years.  These include: Agency FDA inspections, PAI rehearsal inspections, vendor audits/and customer audits, and ISO. 

EDUCATION/CERTIFICATES: 

● B.S.,Indiana Institute of Technology, Fort Wayne, Indiana.

● Ten professional continuing education certificates completed to date. 

● 6 Sigma Green Belt Certification from Villanova University. 

● IATF Lead Auditor Certification. 2021/IATF Core Tools Certification, 2021, ZEISS Calypso CMM Training, 2021 

● New Hampshire Community Technical College, Batch Culture of Recombinant tPA Secreting CHO Cells. 

● University of Minnesota, Dr. Irving J. Pflug, Microbiology and Engineering of Sterilization Processes 

● AQS Solutions, ISO 9001:2015/ISO 14001:2015 Integrated Auditor Training, Certificate #IA0391.