team leadershipregulatory complianceprocess developmenttechnology transfercgmpprocess characterizationdownstream purificationmicrobial processes
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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$133к-167к/год
$130к$170кмедиана$180к
По похожим ролям (50) ~ $170к/год
85
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Зона ответственности и научное лидерство описаны чётко, но необходимость периодически выходить в смены может влиять на баланс между работой и личной жизнью.
Выходы в смены
Чёткая зона ответственности
Биотехнологии
Мэтч & Сопровод
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Описание вакансии
Текст:
Hirify AI/Оригинал
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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