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6 дней назад

Process Development Principal Scientist (Biotech)

133 000 - 167 000$
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
Process Development Principal Scientist (Biotech): Leading downstream purification development, process characterization, and technology transfer for microbial processes moving to commercial cGMP production with an accent on laboratory studies, process optimization, and regulatory-quality documentation. Focus on directing complex development programs, supporting manufacturing through batch review and deviation management, and mentoring scientists.

Location: USA - CO - Boulder

Salary: $133,000–$167,000 per year

Company

hirify.global provides biopharmaceutical process development and cGMP manufacturing services.

What you will do

  • Lead process development, process characterization, and technology transfer for microbial processes to commercial cGMP facilities.
  • Design and execute laboratory studies for downstream purification unit-operation development and optimization with minimal oversight.
  • Own product development and design decisions, propose manufacturing approaches based on process data, and direct delivery of project objectives.
  • Provide technical support for cGMP manufacturing, including floor coverage, batch-document review, deviations, and change controls.
  • Author and review protocols, reports, and client documentation suitable for publication and regulatory requirements.
  • Mentor, train, coach, and supervise departmental scientists while supporting safety, training compliance, and team performance.

Requirements

  • B.S. in a scientific discipline plus 12+ years of related experience; or M.S. plus 10+ years; or Ph.D. plus 7+ years.
  • Advanced scientific knowledge applicable to process development, downstream purification, and unit-operation optimization.
  • Experience with process characterization, technology transfer, microbial processes, and cGMP manufacturing support.
  • Ability to produce high-quality technical documentation and maintain knowledge of cGMP and other regulatory requirements.
  • Ability to execute experiments with minimal oversight, solve increasingly complex problems, and provide technical leadership.
  • Ability to maintain training compliance, follow safety requirements, and ensure departmental adherence to safety procedures.
  • Must be able to cover shift work as needed to support laboratory activities and organizational needs.

Culture & Benefits

  • Full-time, salaried exempt position.
  • Work includes laboratory and manufacturing-area support, including shift coverage as needed.
  • Role includes mentoring and professional development of scientists and shared ownership of programs.
  • hirify.global is an EEO/AA employer committed to workforce diversity.

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