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2 дня назад

Senior Bioprocess Engineer - Cell Production & Process Development

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
Senior Bioprocess Engineer - Cell Production & Process Development (Cell Production/Regenerative Medicine): Developing and scaling GMP-compliant production processes for primary and iPSC-derived cells with an accent on bioreactor culture, process optimization, and reliable cellular product supply. Focus on leading process development studies, analyzing production data, troubleshooting deviations, and transferring cell expansion methods toward GMP readiness.

Location: Onsite at the Manchester, NH Lab, United States. Flexible hours are required, including the ability to work non-traditional schedules such as Sunday–Thursday or Tuesday–Saturday, with weekend and holiday work as needed.

Company

hirify.global develops therapies for rare diseases and technologies intended to expand the availability of transplantable organs, including manufactured organs and regenerative medicine solutions.

What you will do

  • Plan and execute cell production runs supplying primary and iPSC-derived cells for research and process development.
  • Lead small-to-medium process development studies, including planning, execution, data analysis, risk identification, and recommendations.
  • Develop, review, and maintain laboratory procedures, protocols, technical reports, records, and controlled documentation.
  • Investigate process deviations, troubleshoot technical challenges, and improve manufacturing robustness, consistency, efficiency, and scalability.
  • Evaluate and implement emerging technologies, equipment, and manufacturing strategies, including equipment lifecycle management.
  • Collaborate with Analytical Development, Operations, Tissue Engineering, Quality, and Manufacturing teams; support technical and regulatory documentation and present data.

Requirements

  • Bachelor’s, Master’s, or PhD in biomedical science, cell biology, or a related field.
  • Relevant experience in stem cell therapy, bioreactor cell production, scale-up, regenerative medicine, or tissue engineering: 5+ years with a bachelor’s degree, 3+ years with a master’s degree, or 1+ year with a PhD.
  • Strong experience in cellular process development and/or mid-scale cell production at 2–10 L.
  • Technical expertise in cell bioreactor culture, preferably Sartorius Ambr/B-DCU or vertical wheel bioreactors at scales up to 10 L or more.
  • Experience with laboratory instrumentation and data software, plus strong written and oral communication, organization, and attention to detail.
  • Ability to work onsite in Manchester, NH and accommodate non-traditional schedules, including weekend and holiday work when needed.

Nice to have

  • Experience with automated cell processing equipment such as CliniMACS Plus, LOVO, Cue, Sepax, Sefia, or Rotea.
  • Knowledge of transferring R&D cell expansion methods to GMP.
  • Experience with statistical software such as GraphPad Prism, MODDE, SIMCA, or JMP.

Culture & Benefits

  • Collaborative environment focused on innovation, scientific curiosity, and regenerative medicine.
  • Medical, dental, vision, and prescription coverage for eligible employees.
  • Wellness resources, 401(k), ESPP, paid time off, and paid parental leave.
  • Disability benefits and additional company benefit programs.

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