1 день назад
Analyst, Quality Control, Chemistry & Stability
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Analyst, Quality Control, Chemistry & Stability (Analytical Chemistry/GMP): Performing cGMP quality control testing and supporting global stability programs at a Melbourne manufacturing site with an accent on HPLC, UPLC, particle analysis, and regulated documentation. Focus on executing stability operations, trending data through statistical analysis, troubleshooting methods and equipment, and supporting method transfers and quality investigations.
Location: Melbourne Resilience site, Australia; full-time onsite and not eligible for remote work
Company
develops mRNA-based medicines and vaccines and operates a large-scale mRNA manufacturing facility in Melbourne.
What you will do
- Perform cGMP QC chemistry testing using HPLC, UPLC, UV, dynamic light scattering particle analysis, AEX HPLC, and plate reader-based assays.
- Support global GMP stability programs through sample set downs, pulls, inventory checks, labeling, shipments, and data entry in LIMS and inventory systems.
- Maintain and trend stability data, producing statistical analyses, tables, charts, protocols, and final reports.
- Support internal and external method transfers, method qualification projects, assay troubleshooting, and equipment troubleshooting.
- Complete laboratory operations including reagent preparation, equipment maintenance, and good documentation practices.
- Prepare and contribute to SOPs, protocols, reports, investigations, deviations, CAPAs, change controls, and audit activities.
Requirements
- Bachelor of Science degree in a relevant scientific discipline, preferably Chemistry.
- Five years of Quality Control experience in a cGMP organization, with a focus on analytical chemistry.
- Hands-on experience with HPLC, UPLC, particle analysis, and plate reader-based assays.
- Working experience in a GMP environment and knowledge of FDA, EU, and ICH guidelines.
- Ability to conduct investigations, prioritize multiple projects, and collaborate in a cross-functional matrix environment.
- Must work full-time onsite at the Melbourne Resilience site; remote work is not available.
Culture & Benefits
- Healthcare and voluntary benefit programs.
- Fitness, mindfulness, and mental health resources.
- Family-building support including fertility, adoption, and surrogacy benefits.
- Paid vacation, bank holidays, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
- Savings and investment programs plus location-specific benefits.
- In-person collaboration supported by a 70/30 work model.
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