6 дней назад
Analytical Development Principal Scientist, Microbiology & Viral Safety
140 800 - 211 200$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Analytical Development Principal Scientist, Microbiology & Viral Safety (Biotechnology): Providing strategic and technical leadership for microbiology and viral safety assays across cell and gene therapy and biologics development programs with an accent on assay development, validation, regulatory support, and adventitious agent risk assessment. Focus on leading wet-lab experiments, implementing rapid and alternative microbiological methods, preparing regulatory dossiers, and supporting manufacturing and commercial readiness.
Location: Boston, MA; on-site five days per week
Salary: $140,800–$211,200 per year, plus annual bonus and equity awards
Company
Vertex is a global biotechnology company focused on scientific innovation and the development of products for patients.
What you will do
- Provide strategic and technical leadership for microbiology and viral safety assays across cell and gene therapy and biologics programs.
- Lead the development, qualification, validation, transfer, implementation, and lifecycle management of microbiological and viral safety methods.
- Guide cross-functional teams on microbiological and virological risk assessment, assay selection, testing strategies, investigations, and process changes.
- Author and review technical dossiers, validation plans, protocols, reports, and scientific justifications for regulatory submissions and inspections.
- Drive rapid and alternative microbiological method development with internal stakeholders and external testing laboratories.
- Lead hands-on wet-lab development activities and represent the organization in scientific forums, consortia, and collaborative initiatives.
Requirements
- Advanced degree in Microbiology, Virology, Biological Sciences, Pharmaceutical Sciences, or a related field; PhD preferred, with significant-experience MS candidates considered.
- PhD with 4+ years, Master's with 7+ years, or Bachelor's with 10+ years of relevant experience.
- Significant industry experience in assay development, qualification, validation, transfer, and lifecycle management.
- Strong expertise in microbiology, virology, adventitious agent safety, regulatory expectations, and GMP manufacturing support.
- Experience supporting regulatory submissions, inspections, health authority interactions, and cross-functional collaboration.
- Ability to work on-site in Boston, MA five days per week.
Nice to have
- Experience in cell and gene therapy, biologics, or advanced therapy medicinal products.
- Familiarity with rapid and alternative microbiological methods and implementation strategies.
- Participation in industry working groups, scientific forums, or consortia.
Culture & Benefits
- Continuous learning and support for adopting advances in AI, technology, automation, and industry practices.
- Medical, dental, and vision benefits with paid time off and company shutdowns in summer and winter.
- Educational assistance programs, including student loan repayment.
- Commuting subsidy, charitable donation matching, and 401(k).
- On-site work with ad hoc flexibility under the Flex @ Vertex program.
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