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2 дня назад

Scientist, Analytical Sciences and Technology, Chemistry (Biotechnology)

109 200 - 174 600$
Формат работы
onsite
Тип работы
fulltime
Грейд
middle
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
Scientist, Analytical Sciences and Technology, Chemistry (Biotechnology): Supporting analytical method lifecycle management for commercial and late-stage development programs with an accent on chemistry-based methods, HPLC/UPLC, validation, troubleshooting, and GMP compliance. Focus on investigating OOS/OOT results, analyzing analytical data, authoring inspection-ready documentation, and driving improvements across QC laboratories, manufacturing, and external testing partners.

Location: Norwood, Massachusetts, United States; U.S. persons only due to export-control requirements

Salary: $109,200–$174,600 per year, plus potential bonus, incentive compensation, or equity.

Company

hirify.global develops mRNA-based therapeutics and vaccines through its technology platform, delivery technology, and manufacturing capabilities.

What you will do

  • Lead and support chemistry-based analytical method transfers, validations, verifications, comparability assessments, and lifecycle management.
  • Provide technical expertise for HPLC/UPLC, chromatographic methods, compendial testing, and analytical instrumentation.
  • Troubleshoot analytical issues affecting laboratories, manufacturing, and product disposition, identifying root causes and corrective actions.
  • Support OOS, OOT, deviation, atypical-result, and laboratory investigations through scientific data analysis.
  • Author, review, and approve protocols, reports, methods, specifications, investigations, and SOPs.
  • Collaborate with Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs, CMOs, and contract testing laboratories to support inspection readiness and network harmonization.

Requirements

  • Bachelor’s degree with 5+ years, master’s degree with 3+ years, or PhD with 0–2 years of relevant industry experience in analytical chemistry, chemistry, biochemistry, pharmaceutical sciences, chemical engineering, or a related discipline.
  • Experience with analytical method transfer, qualification, validation, verification, or lifecycle management in a GMP-regulated pharmaceutical, biotechnology, biologics, or vaccine environment.
  • Experience authoring and reviewing technical documents and supporting laboratory investigations, including OOS and OOT assessments.
  • Working knowledge of GMP regulations, data integrity principles, pharmaceutical quality systems, and scientific data analysis.
  • Experience collaborating with Quality, Manufacturing, Regulatory Affairs, and external partners.
  • Must qualify as a U.S. person under U.S. export-control laws; non-U.S. persons are not eligible and visa sponsorship is unavailable.

Nice to have

  • Hands-on expertise with HPLC/UPLC, chromatographic method execution, troubleshooting, and data interpretation.
  • Knowledge of ICH, USP, FDA, EMA, and other global health-authority requirements.
  • Experience with CAPAs, deviation management, change controls, analytical control strategies, regulatory filings, or commercial manufacturing support.

Culture & Benefits

  • Healthcare 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 year-end shutdown.
  • Savings and investment programs, plus location-specific benefits.

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