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4 дня назад

Principal Research Associate, Analytical Development (Biotech)

89 900 - 143 800$
Формат работы
onsite
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
Principal Research Associate, Analytical Development (Biotech): Developing, transferring, qualifying, and validating analytical methods for clinical-stage and commercial pharmaceutical operations with an accent on HPLC, molecular biology assays, method readiness, and regulatory expectations. Focus on troubleshooting complex assay issues, leading investigations, interpreting analytical datasets, and coordinating method performance across Analytical Development, Quality Control, Analytical Sciences, and Quality Assurance.

Location: Norwood, Massachusetts; site-based full-time with no remote work eligibility. Candidates must already hold U.S. work authorization and qualify as U.S. persons under applicable export control requirements.

Salary: $89,900–$143,800 per year, with potential discretionary bonus, incentive compensation, or equity.

Company

hirify.global develops mRNA medicines and operates a biotechnology platform focused on transforming how medicines are created and delivered.

What you will do

  • Act as a liaison between Analytical Development, Analytical Sciences & Technology, Analytical Technical Operations, Quality Control, and Quality Assurance.
  • Ensure analytical methods meet technical, operational, and regulatory requirements before qualification or validation.
  • Support investigations into assay performance issues, identify root causes, conduct hypothesis testing, and implement solutions.
  • Drive assay optimization and continuous improvement based on robustness, operational feedback, and lifecycle requirements.
  • Support deviation investigations, CAPAs, and change controls related to analytical methods.
  • Analyze complex datasets and author or review protocols, reports, and method lifecycle documentation.

Requirements

  • MS with 5 years, or BS with 8 years, of biotech or pharmaceutical analytical development experience.
  • Hands-on experience with HPLC, absorption methods, and molecular biology assays.
  • Experience transferring analytical methods to Quality Control or external laboratories.
  • Experience troubleshooting complex assays and leading investigations in GMP or late-stage development environments.
  • Understanding of critical quality attribute frameworks, assay lifecycle management, and regulatory expectations.
  • Full-time on-site presence in Norwood, Massachusetts is required; U.S. work authorization and U.S. person status are required, and immigration sponsorship is unavailable.

Culture & Benefits

  • Healthcare coverage and voluntary benefit programs.
  • Fitness, mindfulness, and mental health support.
  • Family planning benefits, including fertility, adoption, and surrogacy support.
  • Paid vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
  • Savings and investment programs, plus location-specific benefits.

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