Douglas H. Clark
Bio-Douglas H. Clark
About-
Douglas H. Clark cGMP Brief Technical Experience Overview:
Led 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.
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.
I have been a key member of corporate due diligence technology acquisition teams.
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.
Team member for a startup and cGMP efforts for a newly constructed multi-million-dollar Immunotherapy clean room cGMP plant.
My team delivered the first phase of the 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.
Resume-Douglas H. Clark
SUMMARY: Goal-oriented, efficient manufacturing operations/quality leader with extensive management/human resources/hands-on operations experience and customer satisfaction, and budget for both private companies and Fortune 500 industrial based companies that includes 3rd party contract manufacturing management, including product packaging responsibilities, and supplier management/supplier qualification experience.
AREAS OF EXPERTISE/CORE COMPETENCIES:
ISO 9001:2015/ISO 14001
Flexible/Adaptable
Culture/Improvement/Staffing
ERP Systems/$350MM Projects
Entrepreneurial Spirit
Packaging/Labeling/Cold Chain
Internal/External Out Sourcing
Single-Use/Medical Device
Customer Centric Approach
Green Belt 6 Sigma, Villanova
Continuous Improvement
Agent of Change/Human Resources
Lean Manufacturing
Just-in-Time Production
Cost Reduction/Avoidance
SPC Monitoring/ISO 13485
Optimizing Processes
‘Can-Do’ Mentality
● Successfully led high profile cross-functional 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 Immunotherapy experience, silicone injection molding, thermoforming for drug packaging, single-use technology, and new plant startup.
PROFESSIONAL EXPERIENCE:
Responsible for oversight of the (QMS), Quality Management System that operates in compliance with ISO 9001:2015 requirements.
• Responsible for: document control and review/approval of controlled documents; implementation of change management and review of all change controls; implementation of supplier quality management and performance of supplier audits; root cause analysis/CAPA; implementation of effective internal Audit Program; ensured robust Training Program; implementation of applicable equipment, calibration, first article inspections, ISO AS 9100 Monel welding for military and space contracts, labeling, product controls; Gamma sterilization and test methods for sterile products; including testing laboratories/oversight of 3rd party thermoforming, rotary, and silicone-injection molding/single-use solutions and; and oversight of third party clean room/suppliers. Actively managed the supplier audit program that included performance score card metrics and supplier visits.
In conjunction with other industry consultants, provide quality and operation services, and guidance to companies dedicated to producing biologics/medical devices/food/beverage/packaging/plastics/CNC film packaging. Expertise, and guidance dedicated to manufacturing and (CMO) contract manufacturing companies/supporting new plant startup and equipment (FAT) factory acceptance testing and commissioning services. Injection molding, plastics, food/beverage industry, cell culture, single-use technology/packaging. Supporting cGMP, DEA products, ISO, CFR Parts 210, 211, ISO 13485, and 820. Human resources/operations leader for recruitment/business strategies that guaranteed the organization was appropriately staffed, by attracting, selecting and maintaining top consultants. Coaching and supporting consultants on performance improvement plans, conflict resolution, and client feedback/overall performance. Proven track record of building and driving successful talent strategies and processes that meet business objectives.
Responsible for the facilities and engineering associated with the modular cleanroom installation, construction, high-volume startup staffing, start-up, and FDA inspection readiness of a multi-shift, high volume aseptic immunotherapy manufacturing facility dedicated to PROVENGE®. This facility was the first cellular immunotherapy facility approved by the FDA in the US for this type of manufacturing.
Dedicated to (IBO) Indy Bulk Operations that included supporting manufacturing plant sites for multi-billion-dollar FDA licensed insulin franchise. Managed quality system documents, updated and revised as necessary. Worked directly with production to ensure that cGMP quality requirements were met. Provided oversight for maintenance of quality programs, systems, processes and procedures that ensured compliance with cGMPs and policies. Attended regular production walks ensuring that any quality issues were addressed real time. Helped to ensure that a Right First Time culture was distilled helping to reduce down time and constantly driving continuous improvement.
Supported new facility startup for a 3,000L perfusion cGMP biologics bioreactor plant. Tasks included heading up the new large-scale inoculum preparation laboratory, and purchasing new laboratory equipment and supporting (FAT) Factory Acceptance Testing and commissioning tasks.
OTHER RELEVANT EXPERIENCE
Manufacturing team member responsible for start-up responsibilities and manufacturing activities for a $145M, 148,000 square foot multi-shift, cGMP biopharmaceutical cell culture plant. The facility was fully automated and contained two 5000L bioreactors used for the production of Keliximab®. Successfully responsible for establishing, executing, monitoring, and delivering on goals associated with the delivery and commissioning of the bioreactor manufacturing area. Cross-functional and decision-making teams that managed aggressive project schedules.
Managed 24/7 high-volume cGMP cell culture contract manufacturing operation dedicated to producing contract manufacturing drug product runs employing a collagen bioreactor microsphere cell culture technology that included OP-1 medical device for Stryker. Responsible for: management of the bioreactor value stream, P/L, hiring new staff and training, performance evaluations, asset management, setting goals and budget, prepared directives outlining policy, human resources, internal/external audit outcomes.
EDUCATION/CERTIFICATES: ● B.S., Business Administration/Human Resources, Indiana Institute of Technology, Fort Wayne, Indiana, 2004. ● 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.