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Scientist, Analytical Sciences and Technology

109 200 - 174 600$
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
Scientist, Analytical Sciences and Technology (Analytical Method Lifecycle Management): Supporting analytical method transfers, validations, investigations, and continuous improvement for commercial and late-stage pharmaceutical and vaccine programs with an accent on GMP compliance, method performance, and cross-functional technical leadership. Focus on troubleshooting analytical issues, analyzing OOS/OOT data, developing CAPAs, and ensuring inspection-ready documentation across internal laboratories, manufacturing operations, and external testing partners.

Location: Norwood, Massachusetts, United States; 70% in-office work model. Due to U.S. export control requirements, only U.S. persons are eligible, and non-U.S. persons cannot be sponsored for an export control license.

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

Company

hirify.global develops mRNA technology and medicines, including biologics and vaccines.

What you will do

  • Lead and support analytical method transfers, validations, verifications, and comparability assessments across internal and external laboratories.
  • Provide technical leadership for analytical method performance monitoring, lifecycle management, and continuous improvement.
  • Troubleshoot analytical issues affecting laboratory operations, manufacturing, and product disposition, including root-cause analysis and corrective actions.
  • Support OOS, OOT, deviation, atypical-result, and laboratory investigations, using scientific data analysis to identify trends and risks.
  • 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 compliant analytical execution and inspection readiness.

Requirements

  • Bachelor’s degree in a relevant scientific discipline and 5+ years of industry experience, or a master’s degree and 3+ years, or a PhD and 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, and pharmaceutical quality systems.
  • Experience authoring and reviewing technical documentation and supporting laboratory investigations.
  • Ability to analyze scientific data, identify trends, solve technical problems, and collaborate across functions.
  • Must qualify as a U.S. person under U.S. export control laws; visa sponsorship is not available for non-U.S. persons.

Nice to have

  • Hands-on experience with chromatographic, spectroscopic, molecular, lipid-based, vaccine, biologics, or biochemical analytical techniques.
  • Knowledge of ICH, USP, FDA, EMA, and other global health authority requirements.
  • Experience with CAPAs, deviation management, change controls, analytical control strategies, and regulatory filing activities.
  • Experience supporting CMOs, contract testing laboratories, or other third-party testing partners.

Culture & Benefits

  • 70/30 work model emphasizing in-office collaboration, teamwork, innovation, and mentorship.
  • Healthcare and voluntary benefit programs.
  • Fitness, mindfulness, mental health, family planning, 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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