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3 дня назад

Scientist, Analytical Sciences and Technology, Chemistry

109 200 - 174 600$
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
Scientist, Analytical Sciences and Technology, Chemistry (Analytical Chemistry): Leading analytical method transfers, validations, troubleshooting, investigations, and lifecycle management for chemistry-based methods supporting pharmaceutical quality control and manufacturing, with an accent on HPLC/UPLC, GMP compliance, and cross-functional technical leadership. Focus on resolving OOS/OOT issues, analyzing complex scientific data, implementing CAPAs, and maintaining inspection-ready analytical documentation across internal and external laboratories.

Location: Norwood, Massachusetts, United States. Only U.S. persons are eligible due to U.S. export control requirements; visa sponsorship is not available.

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

Company

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

What you will do

  • Lead and support chemistry-based analytical method transfers, validations, verifications, comparability assessments, and lifecycle management across internal and external laboratories.
  • Provide technical expertise for HPLC/UPLC, chromatographic, compendial, and other chemistry-based analytical methods and instrumentation.
  • Troubleshoot analytical issues affecting laboratories, manufacturing operations, and product disposition, identifying root causes and corrective actions.
  • Support OOS, OOT, deviation, atypical-result, and laboratory investigations, including scientific data analysis and CAPA development.
  • Author, review, and approve protocols, reports, methods, specifications, investigations, and SOPs while supporting regulatory submissions, inspections, and audits.
  • Collaborate with Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs, CMOs, and contract testing laboratories to harmonize analytical practices and improve testing strategies.

Requirements

  • Must be a U.S. person eligible to access export-controlled information; non-U.S. persons cannot be sponsored for an export control license.
  • Bachelor’s degree in analytical chemistry, chemistry, biochemistry, pharmaceutical sciences, chemical engineering, or a related discipline with 5+ years of relevant industry experience; or a master’s degree with 3+ years; or a PhD with 0–2 years.
  • Experience with analytical method transfer, qualification, validation, verification, or lifecycle management in a GMP-regulated pharmaceutical, biotechnology, biologics, or vaccine environment.
  • Working knowledge of GMP regulations, data integrity principles, pharmaceutical quality systems, and laboratory investigations.
  • Hands-on experience with HPLC/UPLC, chromatographic method execution, troubleshooting, data interpretation, and scientific trend analysis.
  • Ability to author technical documents, solve complex analytical problems, and collaborate across Quality, Manufacturing, Regulatory, and external partner functions.

Nice to have

  • Experience with ICH, USP, FDA, EMA, and other global health authority or compendial requirements.
  • Experience leading CAPAs, deviation management, change controls, analytical control strategies, regulatory filings, or commercial manufacturing support.
  • Experience with digital and data-driven analytical operations initiatives.

Culture & Benefits

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

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