Jakarta Metropolitan Area
Self-motivated and detail-oriented professional trained in bioprocess engineering. Over a year of experience in the biopharmaceutical industry with broad exposure to R&D, project management, and production divisions. Eager to further develop bioprocessing skills.
Topic: Metabolic Engineering of P. pastoris for Hyaluronic Acid Production
• Worked in the formulation and fill-and-finish department for vaccine and monoclonal antibody products (Grade C and A/C cleanroom facilities), maintaining high standards according to cGMP and aseptic practices. • Executed daily production activities, including media fills, process validation, and commercial production trials. • Coordinated SAT/IOQ for a multi-platform aseptic filling machine (pre-filled syringes, cartridges, and vials). • Performed root cause investigations of deviations in line with QA procedures. • Created and managed documentation related to deviation handling, including event initiation, deviation reports, CAPA, and change control according to GDP and ALCOA practices. • Developed SOPs for supporting routine activities (sterilisation, sanitation, etc.) and ensured personnel were trained accordingly. • Collaborated with the R&D department to develop batch records, ensuring smooth process flow and robust product/packaging material accountability.
• Laid out project timelines, goals, and deadlines, and monitored the execution of bioprocessing equipment commissioning projects, from SAT, IQ, OQ, and PQ. • Coordinated the qualification of an automated visual inspection machine for recombinant erythropoietin products. • Prepared weekly progress slide decks to update managers and stakeholders on project status, milestones, and issues. • Organised and led progress review meetings between internal departments (Production, Engineering, Quality Assurance, etc.), local vendors, and foreign vendors. • Facilitated collaborations between the company and vendors to troubleshoot bottlenecks that arise throughout the project execution.
• Provided technical recommendations for the process development of biopharmaceuticals (monoclonal antibodies, mRNA vaccines, gene therapies). • Published internal white papers on the latest bioprocessing equipment technologies compiled from vendor meetings and literature reviews. • Created cGMP-compliant documents (gap analysis and quality risk management) within the technology transfer framework.
• Assisted in the following courses: Bioprocess Equipment Design, Separation Process Engineering, Biological Transport Phenomena, Physical and Analytical Chemistry (practicum), Molecular Biology, Mechanical and Heat Physics. • Responsibilities included tutoring a class of 50+ students, offering assistance with any learning problems outside the class, and assisting lecturers in grading students' assignments.
PT. Life Cycle Indonesia is an environmental consulting company which specializes in end-to-end sustainability and life cycle analysis. Activities and Responsibilities: • Conducted an extensive literature review on mass balance, energy balance, and emissions of the global fiberglass industry. • Analysed the industry impact on global warming using the software SimaPro. • Interpreted the result in relation to the concept of sustainability and the relative impact of the industry on total greenhouse gas emissions. • Formulated potential measures to minimize the environmental impact.