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22 часа назад

Analyst, Quality Control, Chemistry & Stability (Biotech)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US/Australia
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Analyst, Quality Control, Chemistry & Stability (Biotech): Performing cGMP quality-control chemistry testing and supporting global stability programs with an accent on HPLC, UPLC, particle analysis, LIMS workflows, and regulatory compliance. Focus on executing stability operations, trending analytical data, troubleshooting methods and equipment, and contributing to method transfers, investigations, CAPAs, and change controls.

Location: Melbourne, Australia; site-based and full-time onsite. Not eligible for remote work.

Company

hirify.global develops mRNA medicines and operates a Melbourne-based large-scale mRNA vaccine manufacturing facility focused on strengthening Australia’s pandemic resilience.

What you will do

  • Perform cGMP QC chemistry testing using HPLC, UPLC, UV, dynamic light scattering particle analysis, 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.
  • Trend stability data using statistical analysis and prepare stability tables, charts, protocols, and final reports.
  • Support internal and external method transfers and contribute to method qualification projects with Analytical Sciences & Technology teams.
  • Perform reagent preparation, equipment maintenance, assay troubleshooting, and other cGMP laboratory operations.
  • Prepare and review SOPs, protocols, reports, investigations, deviations, CAPAs, and change controls, as well as support audits and inspections.

Requirements

  • Bachelor’s degree in a relevant scientific discipline; Chemistry is preferred.
  • 5 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 and regulations.
  • Ability to conduct investigations, prioritize multiple tasks, and collaborate in a cross-functional matrix environment.
  • Ability and requirement to work full-time at the Melbourne site.

Culture & Benefits

  • Healthcare and voluntary benefit programs.
  • Fitness, mindfulness, and mental health resources.
  • Family-building benefits, including fertility, adoption, and surrogacy support.
  • Paid vacation, bank holidays, volunteer days, sabbatical, global recharge days, and year-end shutdown.
  • In-person collaboration supported by a 70/30 work model.
  • Pre-employment and periodic medical assessments may apply in accordance with legal and operational requirements.

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