Product Development Project Management
Resume:
John Paul Buyondo
** ***** ****, *********, ** 14625 Mob: 315-***-**** ad5rq3@r.postjobfree.com SUMMARY:
Ph.D. in Bioprocess Engineering with over 10 years’ experience in process design and product development for cGMP manufacturing facilities for the production of medical devices, pharmaceutical drugs, vaccines and dietary health supplements. Areas of expertise include project planning and budgeting, plant design and engineering, process and product development, process scale up, process and equipment commissioning, process modeling, process validation, data analysis and optimization, cGMP, HACCP, CAPA, project management, Failure mode & effect analysis (FMEA), Root cause failure analysis (RCFA) and Process safety management. Hands on experience with SuperPro and Aspen Batch Process Developer, and Statistical softwares Minitab and JMP EXPERIENCE
Chief Manufacturing Officer
Rapid Diagnostics Test Kits Manufacturing Facility Microhaem Scientifics, Uganda, East Africa Feb 2023 – April 2024
• Identify technology transfer companies and work with both teams to establish manufacturing processes required to produce high quality products including HIV, Malaria and Sickle Cells Rapid Diagnostic Testing kits.
• Facility design and validation for different cleanroom classifications including ISO 5, ISO 7, ISO 8 and ISO 9.
• Develop and execute protocols for Design Qualification (DQ), Factory Assessment Test (FAT), Site Acceptance Test (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for HVAC system, Air Handling Units, dehumidifiers, dynamic passboxes and static passboxes.
• Work with contractor to design, install and validate water systems for purified water and molecular grade water following World Health Organization (WHO) guidelines.
• Work with regulatory authorities to obtain certification of manufactured products including Uganda National Drug Authority, WHO/ERPD and ISO 13485.
• Identify required production equipment and qualify vendors to supply the needed equipment.
• Develop and train production and engineering SOPs.
• Establish production workflow and assembly methods to maximize efficiency of manufacturing operations.
• Developing and implementing policies and procedures that improve production efficiency, quality, and safety.
• Ensuring that manufacturing processes and equipment are maintained and repaired to minimize downtime and ensure high levels of productivity.
• Gather, organize & analyze data to develop solutions & alternative methods of proceeding; execute continuous improvement projects to optimize operations to deliver process improvements
• Assist CAPA teams, and other project teams, in the development of action plans and implementation schedules, and the verification of completed actions.
Quality Assurance (QA) Validation Engineer
Regeneron Pharmaceuticals Inc, Rensselaer, NY July 2022 – Jan 2023
• Wrote developmental and initial validation protocols for cleaning validation for clean in place (CIP) and clean out of place
(COP) equipment, which included determination of swab and sample locations, determination of worse case equipment, specifying recipe parameters for validation cycle, and specifying acceptance criteria.
• Prepared and oversaw execution of cleaning validation protocols for different production equipment including fermentation vessels, centrifuges, chromatography, and filtration equipment.
• Collected different samples during cleaning validation such as swabs, and final water rinse and submitted the samples to the lab for analysis of different parameters such as pH, TOC, conductivity, etc.
• Prepared and executed steam in place (SIP) validation protocols for different production equipment which included; performance of pre and post calibrations for thermocouples (T/Cs) or data loggers, installation of T/Cs and data loggers into testing locations, running of T/C or data logger systems, installation of biological indicators (BIs) into testing locations, download and analysis of temperature data, statistics, and reports as well as submission of BIs to lab for testing.
• Prepared and executed protocol for establishment of the temperature mapping for the melting of several bottles of culture media in an autoclave.
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Manufacturing Technology – Black Belt Process Engineer IFF (Former DuPont) Nutrition and Biosciences, Rochester, NY July 2017 – Jun 2022
• Commissioned state-of-art $100 million fermentation plant to expand site probiotics production capacity by 100%.
• Provide day-to-day engineering support to operations and use process data analysis for efficient troubleshooting and continuous improvement of the processes to achieve daily plant OEE (Overall Equipment Effectiveness) and TEEP (Total Effective Equipment Performance).
• Development and execution of validation plans for production equipment Clean- In-Place (CIP) and sterilization-In-Place (SIP) to meet cGMP, FDA, HACCP, FSSC 22000 and Kosher standards.
• Design process, temperature and hold time conditions for optimal growth media sterilization for both continuous heat exchanger and batch sterilization systems.
• Development and execution of capital projects and process improvements that enhance plant safety, product quality, and plant OEE.
• Perform root cause failure analysis (RCFA) to identify human, physical and systemic factors responsible for product quality and process safety failures and generate corrective and preventive action plan (CAPA) to eliminate causes of non-conformities.
• Develop and communicate to operations new or improved plant designs using process flow diagrams, P&ID’s, process narratives and energy and mass balances.
• Collect and analyze process manufacturing data with Minitab to continuously improve product quality, plant productivity and safety.
• Team member of the site food safety, cGMP and HACCP committee which involves plant audits to meet FDA and dietary supplement ingredient (DSI) standards.
• Identify equipment and instrumentation suppliers to meet process requirements and specifications, work with vendors to acquire required equipment and contractors to install the equipment.
• Collaborate with company manufacturing and research groups to transfer technology from laboratory or pilot scale process development to commercial
• scale manufacturing.
• Develop batch production records and train operations on how to use and maintain such records. Biotechnology Research Specialist
Buckman International Laboratories, Memphis, Tennessee, USA Dec 2012 – Jun 2017
• Partnered with R & D, manufacturing and sales associates in exploring and understanding the needs of the company for improving existing methods and innovating new biotechnological procedures and products.
• Generated data on new enzyme products and formulations for marketing and/or regulatory affairs including developing product material safety data sheet (MSDS).
• Downstream processing of fermentation broth by centrifugation, microfiltration and dialfiltration to obtain a clean and concentrated enzyme product.
• Maintenance and troubleshooting of fermentation upstream and downstream processing equipment including fermentation and membrane equipment control systems.
• Provided to sales and marketing associates technical assistance required for newly developed enzyme products during product launch and at customer trial site.
• Developed and wrote new and/or improved testing methods for new and existed enzyme products and applications.
• Developed product for optimization of the growth of yeast for corn ethanol commercial production.
• Carried out bio-burden audits of corn ethanol plants and designed a protocol to control bacterial contamination.
• Designed and developed a method to apply oxidizing based bacterial control product for corn ethanol plants.
• Industrial enzymes production and application for corn ethanol, paper, pulp, leather and oil and gas industries.
• Designed and optimized fermentation media and processes using statistical tools for production of industrial enzymes.
• Designed and executed of a set of in-situ 5 L and 20 L batch and fed-batch fermentation experiments for production of enzymes using fungal, bacterial and yeast cells with New Brunswick and Sartorius fermentation systems.
• Active searching and developing of new enzymes, enzyme technologies and applications for pulp, paper, water, leather, corn ethanol, oil and gas industries
• with much emphasis put on patentable industrial applications and technologies. EDUCATION
PhD. Bioprocess Engineering
State University of New York, College of Environmental Science and Forestry, USA Aug 2009 – Dec 2013 Page 3 of 3
MS. Chemical Engineering
Xiamen University, Xiamen, PR China Sept 2007 – July 2009 BSc. Food Science & Technology
Makerere University, Kampala, Uganda Sept 2001 – July 2005 PUBLICATIONS
• John P Buyondo and Percy Jacquess. Method to enhance yeast growth for fermentative bioproduct production, and nutrient composition for same. US10767197.
• John P Buyondo, Mark L Reed and Janse Bernard. Synergistic combinations of monochloramine and peroxide compound, and methods of using the same for microbial control. US20190239511A1.
• John P Buyondo, Mark L Reed and Janse Bernard. Synergistic combinations of monochloramine and organic acid, and methods of using the same for microbial control.US20190230932.
• Peer reviewed journal articles
• Buyondo J.P and Liu S. Unstructured Kinetic Modelling of Batch Production of lactic acid from hemicellulosic sugars. Journal of Bioprocess Engineering and Biorefinery, 2013; 2: 40 – 45.
• Buyondo, J.P and Liu, S. Lactic acid production by Lactobacillus pentosus from wood extract hydrolysates. Journal of Science and Technology for Forest Products and Processes, 2011; 1: 38 – 40.
• Buyondo, J.P and Liu, S. Processes and bioreactor designs for butanol production from lignocellulosic biomass. Journal of Bioprocess Engineering and Biorefinery, 2012; 1:53 – 68. BOOK CHAPTER
• Liu S., Wang YG., Buyondo J.P, Wang YN, and Garver M. Biochemical conversion. In Stuart P.R and El-Halwagi M. Integrated Biorefineries: Design, Analysis and Optimization, 2013 (PP 591 – 650). Taylor & Francis, Boca Raton, FL, USA.
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