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3 часа назад

Staff Technical Operations Scientist (NGS)

157 675 - 221 550$
Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
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
Staff Technical Operations Scientist (NGS): Supporting manufacturing, quality control, and clinical laboratory operations for early cancer detection diagnostics with an accent on technology transfer, process validation, GMP compliance, and NGS workflows. Focus on leading root cause investigations, CAPA and change-control activities, statistical process analysis, and continuous improvement of regulated manufacturing processes.

Location: Hybrid role based in Brisbane, California, United States

Base salary: $157,675–$221,550 per year, plus potential equity, cash bonuses, and benefits.

Company

hirify.global develops life-saving diagnostics focused on early cancer detection.

What you will do

  • Provide scientific and technical guidance for Manufacturing, Quality Control, and Clinical Laboratory operations.
  • Monitor process performance and analyze manufacturing and QC data to identify trends, variability, and improvement opportunities.
  • Lead investigations into nonconformances, out-of-specification results, and process excursions using root cause analysis.
  • Author nonconformance reports, CAPAs, change controls, risk assessments, validation documents, and technical reports.
  • Lead process validation, equipment qualification, technology transfer, and manufacturing/QC readiness activities.
  • Present technical findings and collaborate with cross-functional teams on corrective actions, process reliability, and product quality.

Requirements

  • Bachelor’s degree in Chemistry, Biology, Biochemistry, Biomedical Engineering, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline.
  • 12 years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
  • Experience with NGS workflows and chemistry, GMP-regulated environments, CAP/CLIA, ISO 13485, or IVD environments.
  • Knowledge of process validation and test method validation principles.
  • Experience with manufacturing investigations, CAPA, change control, or quality systems.
  • Experience with automated liquid handling systems such as Hamilton or Tecan, and statistical software such as JMP, Minitab, Python, or R.

Nice to have

  • Exposure to Lean, Six Sigma, or continuous improvement methodologies.
  • Experience with NetSuite, LIMS, or electronic batch records.

Culture & Benefits

  • Hybrid work arrangement at the Brisbane headquarters.
  • Opportunity to contribute to early cancer detection diagnostics.
  • Equity and cash bonus eligibility.
  • Medical, financial, and other benefits depending on the position offered.
  • Equal-opportunity workplace that values diversity.

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