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Principal Scientist (Lyophilization)

99 200 - 165 400$
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
Principal Scientist (Lyophilization): Supporting the design, development, technology transfer, validation, and lifecycle management of sterile pharmaceutical manufacturing processes with an accent on PC1 products and lyophilization operations. Focus on designing scientific studies, analyzing process variability, troubleshooting manufacturing and equipment issues, and developing robust process control strategies.

Location: Hybrid in McPherson, Kansas, United States. Candidates must be authorized to work in the U.S. by any employer and have permanent U.S. work authorization. U.S. work visa sponsorship is not available. Limited travel and occasional non-standard work hours may be required.

Annual base salary: $99,200–$165,400, plus a 12.5% bonus target and eligibility for a share-based long-term incentive program.

Company

hirify.global develops and manufactures pharmaceutical products, including sterile injectable medicines.

What you will do

  • Design, develop, evaluate, and implement new or revised sterile pharmaceutical manufacturing processes.
  • Design and execute experimental protocols and engineering studies to evaluate process performance, variability, scalability, and critical process variables.
  • Analyze data, prepare technical reports, and support product characterization, analytical methodologies, and inspection readiness.
  • Lead or support deviation investigations, root cause analysis, CAPA development, and troubleshooting of process and equipment issues.
  • Support PC1 product lifecycle activities, including technology transfer, scale-up, process validation, CPV monitoring, change control, and post-approval changes.
  • Act as the lyophilization subject matter expert, supporting cycle optimization, equipment capability assessment, process control strategies, and technical training.

Requirements

  • Bachelor’s degree with 4+ years of experience, master’s degree with 2+ years, PhD with 0+ years, associate’s degree with 8+ years, or high school diploma with 10+ years of relevant experience.
  • Experience in Technical Services, Manufacturing Science & Technology, or pharmaceutical manufacturing.
  • Experience with process development, validation or technology transfer, and manufacturing process investigations and troubleshooting.
  • Working knowledge of cGMP and regulatory requirements, with strong analytical, problem-solving, and communication skills.
  • Permanent U.S. work authorization is required; visa sponsorship is not available.

Nice to have

  • Experience with product lifecycle management, CPV, change control, and post-approval changes.
  • Experience with sterile injectable manufacturing and lyophilization process development or troubleshooting.
  • Experience in cross-functional and project team environments.
  • Familiarity with digital or AI tools for data analysis and productivity.

Culture & Benefits

  • Hybrid work arrangement with limited travel.
  • 401(k) plan with hirify.global matching contributions and an additional retirement savings contribution.
  • Paid vacation, holidays, personal days, caregiver and parental leave, and medical leave.
  • Medical, prescription drug, dental, and vision coverage.
  • Relocation assistance may be available based on business needs and eligibility.

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