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12 дней назад

Scientist, CMC Quantitative Sciences (Biotechnology)

109 200 - 174 600$
Формат работы
onsite
Тип работы
fulltime
Грейд
middle/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, CMC Quantitative Sciences (Biotechnology): Developing quantitative analyses, models, data solutions, and reusable analytical tools for pharmaceutical product, process, manufacturing, quality, and analytical lifecycle decisions with an accent on statistics, machine learning, predictive modeling, and data engineering. Focus on translating scientific questions into reproducible analyses, leading cross-functional workstreams, and applying GxP and regulatory requirements to complex CMC data.

Location: 100% onsite in Norwood, Massachusetts, United States. Only individuals who qualify as U.S. persons are eligible due to U.S. export control requirements; 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 through a biotechnology platform focused on scientific innovation and pharmaceutical development.

What you will do

  • Plan and execute quantitative analyses, models, and data solutions supporting research, development, manufacturing, analytical, quality, and product lifecycle decisions.
  • Translate scientific and business questions into analytical objectives, select appropriate methods, evaluate assumptions, and communicate conclusions and recommendations.
  • Apply statistics, machine learning, predictive modeling, mechanistic modeling, data science, and data engineering methods.
  • Lead defined projects and workstreams by coordinating contributors, managing timelines, and escalating technical or delivery risks.
  • Build reproducible analyses, code, visualizations, reports, dashboards, pipelines, and analytical tools aligned with GxP expectations.
  • Partner with scientific, engineering, manufacturing, quality, regulatory, and digital teams and contribute to technical reports and regulatory submissions.

Requirements

  • PhD with 0–2 years, MS with 5–8 years, or BS with 8–10 years of experience in statistics, biostatistics, data science, applied mathematics, chemical engineering, biochemical engineering, or a related STEM discipline.
  • Demonstrated depth in at least one quantitative discipline, including applied statistics, machine learning, predictive modeling, data science, mechanistic modeling, data engineering, or digital analytics.
  • Proficiency with R, Python, SQL, and statistical software such as JMP, Statistica, or Minitab.
  • Experience developing reproducible analyses and communicating methods, assumptions, limitations, results, and recommendations to cross-functional partners.
  • Knowledge of ICH, FDA, EMA, WHO, GxP, GMP, data integrity, and risk-based decision-making principles.
  • Must qualify as a U.S. person under U.S. export control laws; non-U.S. persons cannot be sponsored for an export control license.

Nice to have

  • Experience with pharmaceutical or biotechnology development, analytical development, manufacturing, quality systems, or regulated laboratory environments.
  • Experience developing, validating, or deploying machine learning, mechanistic, predictive, or multivariate models.
  • Experience with MES, LIMS, OSI PI, SAP, DeltaV, Chromeleon, laboratory instruments, cloud data platforms, or internal applications.
  • Experience building automated reports, dashboards, applications, data pipelines, or governed digital solutions.

Culture & Benefits

  • In-person, site-based work with direct collaboration and mentorship.
  • Healthcare and voluntary benefit programs, including fitness, mindfulness, and mental health support.
  • Family planning support for fertility, adoption, and surrogacy.
  • Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
  • Savings and investment programs plus location-specific benefits.
  • Smoke-free, alcohol-free, and drug-free work environment.

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