Назад
Company hidden
обновлено 3 дня назад

Associate Director, Assay Validation (NGS)

Формат работы
remote (только USA)/onsite
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:
/
TL;DR
Associate Director, Assay Validation (NGS): Leading analytical validation studies for sequencing-based germline, somatic, and liquid biopsy assays with an accent on regulatory compliance, assay performance characterization, and cross-functional product readiness. Focus on designing validation strategies, analyzing complex performance data, supporting inspections, and building a scalable NGS validation function.

Location: United States remote or Houston, TX; work may take place in an office, remotely, and/or in a laboratory depending on business needs and assigned responsibilities.

Company

hirify.global develops and supports clinical genomics and genetic testing services.

What you will do

  • Lead the planning, design, and execution of analytical validation studies for sequencing-based germline, somatic, and liquid biopsy assays.
  • Develop validation strategies, protocols, reports, acceptance criteria, reference materials, and performance metrics.
  • Partner with Assay Development, Bioinformatics, Quality, and Product teams to align validation with assay design, clinical claims, and product readiness.
  • Analyze validation data and recommend assay optimization, issue resolution, and launch-readiness actions.
  • Support regulatory and laboratory inspections, responses, documentation, and corrective action plans.
  • Mentor scientists and help build a scalable validation function within R&D.

Requirements

  • PhD in Molecular Biology, Genetics, Genomics, or a related discipline with 6+ years of relevant experience, or an M.S. with 8+ years of experience in NGS assay development and validation.
  • Experience leading validation of clinical NGS assays under CLIA, CAP, NYS, or equivalent regulatory frameworks.
  • Strong expertise in NGS library preparation, sequencing platforms, assay performance characterization, and analytical validation parameters.
  • Experience collaborating with bioinformatics teams on pipeline verification and integrated assay validation.
  • Familiarity with quality management systems, design control, and documentation practices.
  • Ability to lead complex projects, influence without direct authority, and collaborate across a matrixed organization.

Nice to have

  • Experience with germline clinical genetic testing or prenatal liquid biopsy testing.
  • Knowledge of NYS clinical test submission requirements or FDA IVD development processes.
  • Experience managing a small team.
  • Familiarity with automation or process scaling for NGS workflows.

Culture & Benefits

  • Work may be performed in office, remote, and laboratory environments based on business needs.
  • Responsibilities require adherence to applicable safety, quality, regulatory, and company requirements.
  • Travel requirements may vary based on business needs.
  • Equal opportunity workplace committed to an inclusive and diverse environment.

Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →