Imelda Imelda
Bundoora,AU
Summary
Currently, I work as a AlbuRx Bulk technician at CSL Behring, where I was previously employed as a manufacturing assistant. I have completed two years of experience in the biotech pharmaceutical industry. I have been involved in the production of numerous biological medicinal products (AlbuRx, Biostate, Prothrombinex VF, and Mono FIX VF) using plasma and proteins. I have knowledge in natural sciences, and automation engineering (Siemens PCS7 & Jakob AG). I have gained interpersonal skills by training new staffs, and engaging in meetings, including leading daily meetings, and giving presentations in our department. I have supported other departments such as Base Fractionation, Privigen, and Facility A Filling SFP (Semi-Finished Product), where I have further developed skills in bio-processing plant. During the COVID-19 pandemic, I was employed as a Pathology Specimen Collector at Melbourne Pathology, gaining experience in dealing with human specimens in the public health sector. I have a bachelor’s degree in biochemistry and a master’s degree in biotechnology and bioinformatics from La Trobe University. My master research thesis focused on optimising feasibility and cost-effectiveness for the detection of deformed wing virus and Varroa destructor in Western honeybees.
Overview
4
4
years of professional experience
Work History
AlbuRx Bulk Technician
CSL Behring
10.2022 - Current
- Bulk Manufacture of large-scale human serum Albumin (AlbuRx) in varied concentrations for diverse world markets
- Daily activities are centred around the shop floor of a plasma fractionation / processing plant located in Broadmeadows, Melbourne
- Supporting the Base Fractionation department by implementing human plasma fractionation and producing Kistler Cohn (KC) and Kistler-Nitschmann Cohn (KNC) paste
- Having a profound understanding in natural sciences and biological medicine products by understanding the function of human Albumin and utilizing the knowledge to optimize the human Albumin production
- This includes taking active ongoing trainings and learning to ensure the compliance with Good Manufacturing Practices (cGMP), Therapeutics Goods Administration (TGA) and Food and Drug Administration (FDA) regulations are met
- Implementation of routine calibration In-Process Control (IPC) testing equipment (Density meter, pH meter, and Sodium Analyzer)
- This involves daily checks and maintenance of equipment before and after usage with minimal supervision
- Collecting AlbuRx bulk data and performing assay validation of product via aseptic sampling and analysis throughout the manufacture of AlbuRx Bulk processes in detailed manner, to ensure process and quality attributes are satisfactory
- Measurement of various In-Process Control/s (pH, density, sodium ions) as per standard measurement ratios and dilutions during different steps of the manufacture of AlbuRx Bulk
- Operating processing tools using Jakob AG (JAG) and Siemens PCS7 automation system to analyze the AlbuRx pharmaceutical development processes
- This includes: Reviewing electronic batch records within the JAG automation system to ensure that the product manufactured satisfies all process parameters and quality attributes
- Monitoring in –house data collected from the data warehouse and presenting via a report to ensure plant robustness
- Establishing strong communication and connection between operators, supervisors, and management to ensure that the manufacturing of human serum Albumin products for commercial use meets the utmost standards of quality and safety to our patients
- This involves both the AlbuRx Bulk and Filling manufacture of human serum Albumin products, not limited to: Execution of continuous improvement initiatives and engaging with internal key stakeholders in accordance with Quality Management Systems (QMS)
- Implementation of cost reducing Initiatives in AlbuRx department
- Providing timely input into problem-solving investigations and assisting with the closeout of manufacturing and process change assessments, deviations, and Corrective and Preventative Actions (CAPA) for the AlbuRx department
- Assisting with regulatory inspections and audits, including coaching new and current staff in the AlbuRx Bulk Department
- Maintained a safe work environment by strictly adhering to established safety protocols and guidelines.
- Trained new technicians on standard operating procedures, ensuring consistency across the team.
- Performed troubleshooting and diagnosis on malfunctioning equipment.
- Completed complex repairs quickly by leveraging strong diagnostic skills and attention to detail.
COVID-19 Pathology Specimen Collector
Melbourne Pathology
01.2021 - 12.2022
- Become a site leader and conducting training for the new pathology collector staff by providing site induction to the team
- Collected biological samples such as mucus and saliva from more than 500+ patients daily for pathological diagnosis
- Responded to patient concerns and implementing changes to accounts to resolve issues
- Maintained cleanliness of the testing booth and testing materials to comply with DHHS guidelines
- Collected and handle samples safely according to the Melbourne Pathology and DHHS procedures
- Adapted in a busy teamwork environment by working closely with pathologists, doctors, and nurses to validate the number of tested patients
- Performed work in a fast-paced environment by entering confidential patient information electronically and on paper in a timely manner
Manufacturing Assistant (Hemostasis)
CSL Behring
01.2022 - 10.2022
- Identified and supported process development and innovation within the manufacturing plant with minimal supervision
- Operated manufacturing equipment following standard operating procedures (SOP) and current Good Manufacturing Practices (cGMP)
- Developed a strong understanding of biological medicinal products by comprehending the functions of Factor VIII, Factor IX, and Factor X proteins within human blood plasma, and utilized the expertise to improve the treatment for Haemophilia
- Utilized Siemens PCS7 automation systems to regulate processing tools for analyzing pharmaceutical products such as Biostate, Prothrombinex VF, and Mono FIX VF
- Calibrated and assessed quality of the product using numerous validation equipment: conductivity meter, pH-meter, Total Organic Carbon (TOC), and Osmometer in detailed manner
- Utilized computational tools to collect and analyze data, including conductivity, osmolar concentration, and levels of organic carbon of Factor VIII, Factor IX, and Factor X proteins
- These calculations determined the purity of the product and guided the addition of chemicals for pharmaceutical development processes
- Performed routine maintenance and environmental site cleaning according to the Health and Safety (EHS), and cGMP guidelines with minimal supervision
- Advanced organizational and follow-up skills by closely collaborating with internal stakeholders such as managers, supervisors, team leaders, and manufacturing operators
- Ensure all production activities are performed according to the production schedule as directed by the Supervisor or Team Leader
- Advanced in computer proficiency by entering data for process control, departmental databases, and spreadsheets
- Made sure that products were produced on time and are of good quality.
- Inspected products and machines to maintain quality and efficiency.
- Organized work to meet demanding production goals.
- Examined incoming materials and compared to documentation for accuracy and quality.
Education
Master of Science - Biotechnology and Bioinformatics
La Trobe University
Melbourne, AU12.2021
Bachelor of Science - Biochemistry
La Trobe University
Melbourne, AU12.2019
Skills
- TGA / FDA Regulated
- CGxP Compliant
- Biotech
- Biological Medicinal Products
- Plasma Processing
- Validation Specialist
- In-process Controls (IPC)
- Testing
- Aseptic Sampling
- Total Organic Carbon (TOC)
- Osmometer
- Conductivity
- Density
- PH Analysis
- Sodium Concentration Analysis
- OHES Management Systems
- Microsoft 360 Business Suite
- Data Management
- Presentation
- Manual Batch Recording
- Electronic Batch Recording
- Documentation
- Jakob AG (JAG)
- Siemens PCS7 Automated Bulk Manufacturing Systems
- Bio-processing Plant
- Biosecurity
- Natural Sciences
- PC-2 Certified Laboratory
- Diagnostics
- Virology
- Biochemistry
- Molecular Biology Techniques
- DNA Extractions
- RNA Extractions
- RT-qPCR
- PCR
- LAMP
- OH&S
- Microsoft Office
- Bioinformatics
- NCBI
- MEGA
- BioEdit
- PrimerExplorer V5
- BLAST
- Primer-BLAST
- Team Focused
- Patient Focused
- Customer Service Orientated
- Safety Conscious
- Organized
- Eye for Detail
- Strong Work Ethic
- Strong Organizational Skill
- Follow-Up Skill
- Transparent Communicator
- Direct Communicator
- Strong Verbal Ability
- Strong Written Ability
- Agile at Issue Resolution
- Problem Solving
- Adaptative Under Pressure
- Willingness to Learn
- Drive to Succeed
- Attention to Detail
- Customer Service
- Works Well Under Pressure
- Multitasking and Organization
Websites
Accomplishments
- 02/01/20, La Trobe International Academic Scholarship
- 02/01/18, La Trobe College Excellence Scholarship
Workemail
imelda.imelda@cslbehring.com.au
Personalemail
imelda.ciptokesuma@gmail.com
Personal Information
Date of Birth: 10/14/98
References
- Ali Hashempour, AlbuRx Bulk Supervisor, CSL Behring, 0435 074 343, Ali.Hashempour@cslbehring.com.au
- Tri Nguyen, Process Specialist & Manufacturing Lead, CSL Behring, 0466 821 399, Tri.Nguyen@cslbehring.com.au
- Jeff Yeoman, Lecturer and Research Project Coordinator, La Trobe University Australia, 0432 483 792, jeff.yeoman@unimelb.edu.au
Degree
- B.S.
- MSc.
Timeline
AlbuRx Bulk Technician
CSL Behring
10.2022 - Current
Manufacturing Assistant (Hemostasis)
CSL Behring
01.2022 - 10.2022
COVID-19 Pathology Specimen Collector
Melbourne Pathology
01.2021 - 12.2022
Bachelor of Science - Biochemistry
La Trobe University
Master of Science - Biotechnology and Bioinformatics
La Trobe University
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