Denny Mahfudin Email & Phone Number

Copenhagen, Dk

Denmark

- Oversee the full system onboarding process, ensuring on-time and within-budget project delivery.- Establish and lead project teams to ensure effective collaboration and achievement of project goals.- Identify and implement new technologies to enhance system efficiency and performance.- Effectively communicate project status and updates to internal and external stakeholders.- Maintain strong vendor relationships and manage SLAs to ensure high system reliability and service quality.- Manage the Manufacturing CAPEX Reinvestment Portfolio to align with strategic business goals.- Provide support for major capital investment projects, ensuring scope, budget, and timelines are met.

Singapore

- Delivered comprehensive validation services to clients encompassing project management, commissioning, qualification, and validation of equipment, processes, and computer system validation (CSV). - Proficient in formulating project and equipment validation plans, conducting risk and impact assessments, executing qualification protocols, and generating validation reports. - Possessed a robust understanding of cGMP regulations and extensive experience in devising and implementing qualification and validation strategies.- Successfully managed commissioning and qualification activities for both new and existing manufacturing plants.

Led management of the project and collaborate with clients and partners by providing strong technical expertise on process/product technologies to support selection, design, optimization, validation, and troubleshooting of pharmaceutical manufacturing processes and GMP-related activities.Responsible for close liaison with the management and key personnel of clients in the definition of process engineering/process development, in line with agreed timeframes. Notable projects include:- Conducted successful mAb facility expansion feasibility study for a biomanufacturing plant in Singapore, achieving a 4x12K increase within the existing 4x6K plant, emphasizing GMP design review and production process simulation.- Led a feasibility study for two drug product filling lines, resulting in 2x faster market entry and a future expansion plan for up to 100% production volume boost in a multi-product facility.- Efficiently managed commissioning and qualification after extended plant shutdown.- Established a compliant quality system aligning with local health regulatory bodies and PIC/s standards for the client's manufacturing site

Responsible for ensuring compliance of all qualification‐validation activities, including cleaning validation, aseptic process simulation, thermal mapping, distribution validation, and visual inspection qualification.- Planned qualification and validation schedule, led and coordinated with a team of 3 QA scientists on completing routine qualification and validation tasks that led to increased productivity of the team by up to 50%.- Collaborated with Production, Engineering, QC, and Supply Chain units to develop qualification schedules that reduce downtime of production by 50%.- Supported FATs, SATs, IQ/OQ of plant and equipment, reviewing documentation according to established regulatory principles and advising team members to deliver best practice- Managed technical aspects of validation at the site and its documentation, including validation master plans development and amendment- Review and approval of SOPs, validation protocols, and reports- Participated actively in maintaining the quality of the manufactured product, including commercial drugs and drugs subjected to clinical trials by maintaining the qualification status of the equipment used and validation lifecycle of the manufacturing process- Acted as SME to support deviations investigations, CAPA implementations, and regulatory audits

Managed teams on shop floor activities in the area of central service operations (media and buffer preparation, dispensing, equipment preparation, including cleaning and sterilization) and fill and finish area (formulation, filling, inspection, and secondary packaging)- Planned production schedule, led and coordinated with a team of 12 Production Scientists and 4 Production Staff on completing routine manufacturing process of drug product and drug substance- Collaborated with engineering, QA, and supply chain units to develop a production schedule to reduce production downtime by 50%.- Led the production team during the technology transfer of new products from the sending unit to ensure smooth process implementation while adhering to regulatory requirements.- Developed cleaning validation activities associated with changing existing processes, implementing new processes, and during the development of new products, including but not limited to cell culture process, chromatography, ultrafiltration, and fumigation cycle development- Review and update the Master Batch Records (MBR), qualification‐validation protocols, and SOPs that led to productivity improvement up to 50%.- Collaborated with the Quality team to achieve proficiency in GMP documentation such as deviations, CAPAs, and change controls that improved the quality of batches.- Represented the production team in internal and external regulatory audits (BPOM, EMA, tech transfer partners) in both front and back‐office support that led to regulatory license approval.

Key member of the project team for the establishment of a new GMP-certified biopharmaceutical facility with a total investment of US$ 35M. - Supervised cleanroom construction of production facilities which included advising on process layout design, machine installation, commissioning, and qualification.- Collaborated with the engineering and quality team on HVAC and cleanroom qualification activities of the production facility.- Conducted machine commissioning and qualification in production facilities, which include 1000L mixing tanks, autoclaves, GMP washer, packaging machines, laminar air flow, TFF units, virus filtration equipment, and chromatography units.- Developed and improved aseptic process simulation of syringe filling lines based on site requirements and best practices while adhering to regulatory requirements.Team player in the downstream manufacturing process of biological drug compounds which includes the purification process using various chromatography units, TFFs, virus filtration units, and final sterile filtration. - Generated SOPs, development protocols, validation and qualification protocols of equipment and process.- Experienced in audit support for the supplier qualification process to improve the quality of material and equipment supplied.

Jakarta

• Involved in theoretical and hands-on training in the upstream and downstream process for the biopharmaceutical industry. - Perform wet lab activities and group projects using mammalian cell culture - Perform purification process using chromatography systems. - Assess the viral clearance activity and its effectiveness in the purification steps• Trained in the concept of Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Quality Management System (QMS), and compliance with current regulatory standards.

Balikpapan

Increased the effectiveness of landfarming process in bioremediation facility plant up to 30% of TPH reduction by using slow-release fertilizers and appropriate bulking agents.