Damjan Pop-Arsov
QC Associate II at Lonza Netherlands, former PharmaCell- Claim this Profile
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Serbian Native or bilingual proficiency
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Italian Professional working proficiency
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Dutch Limited working proficiency
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Macedonian Native or bilingual proficiency
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English Native or bilingual proficiency
Topline Score
Bio
Experience
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Lonza Netherlands, former PharmaCell
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Netherlands
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Pharmaceutical Manufacturing
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100 - 200 Employee
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QC Associate II
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Aug 2022 - Present
Prepared Risk Assessments and authored protocols for Operational and Performance Qualifications (OQ/PQ) of cleanrooms.Performed and documented investigations for environmental monitoring (EM) excursions, as well as major and minor Deviations.Facilitated Change Control, CAPAs and Effectiveness Checks, including initiation, trending and closure.Maintained MODA-EM database of EM samples and authored annual EM reportsPerformed on-the-floor observations and provided guidance and training to personnel on EM strategy implementation.
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mRNA Process and Analytical Development Technician
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May 2022 - Aug 2022
- Worked as process development technician on a temporary 3 month assignment. - Worked on LEAN Six Sigma implementation in the new PD laboratories - Performed various experiments in setting up strategy for production of mRNA, as well as analytic methods (mRNA in vitro transcription, DNA purification, RiboGreen, Akta, HPLC) - Wrote protocols for experiments, both for PD and AD
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Biotech Associate II
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Aug 2021 - May 2022
- Served as Quality Events Lead for the manufacturing team, managing the writing of Deviations and CAPAs, and Change implementation. Reduced overdue quality events from 12 to 0 in six months and ensured adherence to future timelines.- Performed creation and review of Manufacturing Batch Records of the project, following set timelines for batch record closure. - Performed and organized trainings for new starters, including OTF process trainings, cGMP, aseptic technique, SAP, and Deviation investigation/writing. - Extensive experience writing impact assessments and root cause analysis for Manufacturing Deviations. - Coordinated operators during cleanroom activities, as well as preparations for process days. - Provided extensive LIMS trainings during its implementation at the site.
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Biotech Associate
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Feb 2020 - Aug 2021
Extensive experience in aseptic manufacturing of Mammalian Cell Culture and Gene Therapy (CGT) Products under GMP environment.Extensive experience with G-Rex bioreactors.Performed Environmental monitoring activities.Involved in creation and review of Batch Records, Deviations and CAPAs.Expertise in implementation, regulation and assessment of raw materials for use in manufacturing of cGMP products.Performed creation and confirmation of Process Orders.
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UMC Utrecht
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Netherlands
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Hospitals and Health Care
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700 & Above Employee
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Thesis Writing Internship
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Feb 2019 - Jul 2019
Did a thesis writing internship at UMCU on the topic "Epigenetic Mechanisms behind Allelic Imbalance in Cardiomyopahties". Wrote an extensive literature analysis on Allelic Imbalance to present the state-of-the-art knowledge on the relatively recent topic Performed imaging analysis of iPSC-derived cardiomyocytes and detailed the findings in a lab report Contributed to research on the pathogenesis of cardiomyopathy headed by Dr. Magdalena Harakalova, who was impressed by my strong work ethic and analytical skills
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University College Utrecht
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Netherlands
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Research Services
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100 - 200 Employee
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Teaching Assistant
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May 2018 - Jun 2018
I was the Teacher Assistant in a lab course called "Cell Biology and Cellular Signalling". My main tasks included supervising students in the lab, providing assistance to both students and the teachers and giving the teachers feedback on the students and the quality of the course. I was also in large part responsible for teaching the Microscopy part of the course. I was the Teacher Assistant in a lab course called "Cell Biology and Cellular Signalling". My main tasks included supervising students in the lab, providing assistance to both students and the teachers and giving the teachers feedback on the students and the quality of the course. I was also in large part responsible for teaching the Microscopy part of the course.
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Education
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University College Utrecht
Bachelor of Science - BS, Biochemistry and Molecular Biology