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2 дня назад

Senior Principal Scientist (Cell and Gene Therapy)

179 000 - 212 000$
Формат работы
remote (только USA)
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 Principal Scientist (Cell and Gene Therapy): Providing CMC scientific leadership for innovative biologics across process development, analytical development, manufacturing, technology transfer, stability, control strategy, and lifecycle management with an accent on cell and gene therapy and cell-based technologies. Focus on developing evidence-based technical recommendations, overseeing external CDMO and CRO activities, and guiding cross-functional teams through complex development, regulatory, quality, and manufacturing challenges.

Location: Remote, Americas; listed location: Waltham, Massachusetts, United States

Base salary: $179,000–$212,000 per year, excluding potential incentive compensation and equity.

Company

hirify.global is a global biotherapeutics company developing therapies across immunology, hematology, cardiovascular and metabolic, respiratory, and transplant areas using plasma fractionation, recombinant protein, and cell and gene therapy platforms.

What you will do

  • Provide senior scientific and technical leadership for CMC strategy supporting innovative biologics.
  • Assess process and analytical development, characterization, manufacturing, technology transfer, stability, control strategy, and lifecycle management activities.
  • Develop evidence-based, fit-for-purpose recommendations that balance scientific, regulatory, quality, supply, timeline, and business requirements.
  • Serve as a subject matter expert for cell and gene therapy and cell-based therapeutic platforms.
  • Oversee technical work with CDMOs, CROs, technology providers, and strategic collaborators, including scope definition, deliverable review, investigations, and risk mitigation.
  • Partner with cross-functional and international teams while strengthening scientific standards, technical practices, knowledge sharing, and mentoring.

Requirements

  • 8+ years of relevant industry experience in CMC, process engineering, pharmaceutical development, biotechnology, chemical manufacturing, process development, manufacturing, or a related technical discipline.
  • Direct experience with cell and gene therapy and/or cell-based therapeutic platforms.
  • Demonstrated experience in process improvement development and execution, including identifying technical gaps, recommending improvements, and supporting implementation.
  • Experience organizing, developing, and deploying best-practice frameworks, processes, tools, and templates aligned with enterprise standards.
  • 5+ years of experience in a global matrix organization involving cross-functional, multicultural, and international teams.
  • Experience working with external development and manufacturing organizations, including CDMO selection, technical due diligence, technology transfer, governance, and issue resolution.
  • Strong understanding of CMC principles across product and process development, analytical and control strategies, manufacturing, technology transfer, stability, regulatory requirements, and lifecycle management.
  • Ability to influence technical direction through subject matter expertise, evidence-based recommendations, and collaboration in a global, matrixed pharmaceutical or biotechnology environment.
  • Advanced degree in a relevant scientific or engineering discipline preferred; a Bachelor’s degree with significant relevant industry experience will be considered.

Nice to have

  • 5+ years of experience in cell and gene therapy, including senior scientific or technical expertise for complex biologic, cell therapy, gene therapy, or other advanced therapeutic programs.
  • Familiarity with AAV or other viral vectors, baculovirus-based expression systems, insect cell platforms, oligonucleotides, nucleic acid-based therapeutics, recombinant proteins, or other emerging modalities.

Culture & Benefits

  • Full-time employment with benefits information provided through CSL’s candidate resources.
  • Work within a global organization serving patients in more than 100 countries.
  • Culture focused on inclusion, belonging, curiosity, empathy, collaboration, accountability, and continuous improvement.

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