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7 дней назад

Senior Process Scientist (LNP)

59 000
Формат работы
remote (только Europe)/hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US/Europe/Italy
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 Process Scientist (LNP): Developing and overseeing lipid nanoparticle formulation and manufacturing processes for nucleic acid delivery and gene therapy programs with an accent on scale-up, technology transfer, GMP manufacturing, and process controls. Focus on leading outsourced CRO/CDMO activities, troubleshooting complex biologics processes, designing QbD-based control strategies, and supporting CMC documentation through clinical development and commercial launch.

Location: Anywhere in Europe, with hybrid and remote options

Salary: Minimum €59,000 annually when the role is based in Italy; compensation and benefits vary by local market.

Company

hirify.global is an international research-focused biopharmaceutical group developing and commercializing medicines, including treatments for rare and ultra-rare diseases.

What you will do

  • Lead formulation, lipid and excipient screening, LNP process development, manufacturing, and control strategy for assigned gene therapy projects.
  • Advance in vivo LNP programs from candidate selection through clinical development, commercial launch, and lifecycle management.
  • Oversee technology transfers and outsourced development activities with CROs and CDMOs, including partner selection, qualification, governance, and performance monitoring.
  • Review technical plans, batch records, SOPs, development reports, validation protocols, and other manufacturing documentation.
  • Lead troubleshooting, root-cause investigations, deviation assessments, risk management, and continuous improvement activities.
  • Support CMC strategy, regulatory documentation, external business development evaluations, and cross-functional project execution.

Requirements

  • Minimum MSc in biotechnology, bioengineering, biology, biochemistry, chemistry, chemical engineering, or a related field.
  • 5–10 years of relevant industrial experience in biotechnology or pharmaceuticals, including gene editing, CGT/ATMPs, and LNP-based delivery systems.
  • Expertise in LNP formulation optimization, process development, scale-up, GMP technology transfer, process validation, and formulation and process parameters linked to CQAs.
  • Experience with microfluidics, T-mixers, inline mixing, continuous processing, QbD, DoE, CPP/CQA identification, control strategies, and risk assessment.
  • Experience managing CRO/CDMO development activities, technical oversight, troubleshooting, escalation management, and data-driven performance monitoring.
  • Strong understanding of GMP, regulatory requirements, CMC development, technical writing, data review, and stakeholder management in an international matrix organization.

Culture & Benefits

  • Research-focused environment centered on sustainable innovation, reliability, transparency, and ethical behavior.
  • Flexible hybrid and remote working arrangements within Europe.
  • Annual performance-based bonus eligibility.
  • Benefits may include pension, private medical insurance, wellbeing programs, flexible benefits, healthcare programs, and work-life balance initiatives.
  • Relocation support, tax assistance for foreign colleagues, and access to training and development resources.

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