6 дней назад
Senior Director, Analytical Development, Testing and Lab Automation (Cell and Gene Therapy)
226 100 - 339 100$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Director, Analytical Development, Testing and Lab Automation (Cell and Gene Therapy): Setting analytical testing strategies and leading automated testing, laboratory operations, and informatics for cell, gene, and biologic therapy development with an accent on assay automation, process analytical technology, and data integrity. Focus on implementing AI and machine learning tools, building end-to-end laboratory automation platforms, and leading cross-functional scientific and operational teams across multiple programs.
Location: Boston, MA; five days per week on-site
Base salary: $226,100–$339,100 per year, plus annual bonus and equity awards.
Company
Vertex is a global biotechnology company investing in scientific innovation, with a focus on developing cell, gene, and biologic therapies.
What you will do
- Set the analytical testing strategy across multiple cell and gene therapy programs using manual and automated methods.
- Lead testing, operations, and automation teams supporting process development, characterization, and stability studies.
- Oversee development, optimization, and qualification of automated and PAT analytical methods and end-to-end automation platforms.
- Establish laboratory informatics, equipment automation, digitization, data trending, and visualization capabilities, including AI and machine learning tools.
- Manage assay reagents, assay controls, control charts, sample management, data management, documentation, and data integrity practices.
- Build partnerships with Manufacturing, Process Development, Regulatory, Quality, CMC, Digital/IT, and external organizations while managing talent, budgets, and headcount.
Requirements
- Master’s degree or PhD in analytical chemistry, immunology, biochemistry, cell biology, biotechnology, or a related discipline.
- PhD or equivalent with 11+ years of relevant post-doctoral employment experience, or a Master’s degree or equivalent with 15+ years of relevant employment experience.
- Critical experience with cell therapy, biologics, and genetic therapies.
- Extensive experience establishing and leading analytical testing teams, including manual and automated testing strategies.
- In-depth experience with laboratory informatics, AI and machine learning implementation, analytical automation, digitization, data visualization, and PAT method development.
- Strong knowledge of product characterization, process development, stability studies, assay controls, data integrity, and ICH, FDA, and USP guidelines.
Culture & Benefits
- On-site work with ad hoc flexibility under the Flex @ Vertex program.
- Medical, dental, and vision benefits.
- Generous paid time off, including summer and winter company shutdowns.
- Educational assistance, including student loan repayment programs.
- Commuting subsidy, matching charitable donations, and 401(k).
- Equal employment opportunity and reasonable accommodations for qualified applicants.
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