Analytical Development Senior Research Scientist, Imaging Assay Development
Vertex Pharmaceuticals
4 days ago
On-site
Boston, MA
Clinical Research and Development
General Summary:
Senior Scientist to join the Analytical Development team to develop, optimize, and transfer imaging-based assays to automation platforms or QC environments.
Key Duties and Responsibilities:
- Assay Development: Design, develop, optimize, and qualify/validate imaging-based assays to support drug development and manufacturing; evaluate/implement advanced imaging technologies to improve sensitivity, specificity, and throughput; develop robust, reproducible quantitative image analysis methods.
- Technology Transfer: Lead transfer of imaging-based assays to automation platforms or QC environments with regulatory/industry compliance; collaborate with automation, QA, and manufacturing to implement assays; provide technical support and training to QC teams.
- Data Analysis and Interpretation: Analyze and interpret complex imaging data; develop and qualify/validate imaging data analysis pipelines and algorithms.
- Documentation and Compliance: Author/review protocols, reports, and SOPs; ensure compliance with FDA, ICH, USP, and internal quality standards.
- Collaboration and Leadership: Serve as SME; mentor/train junior scientists; collaborate with research, process development, and QA.
Required Knowledge/Skills:
- Analytical development for biologics, cell, and genetic therapy products
- Image-based assay expertise (IHC, IF)
- Confocal microscopy and high-throughput imaging instruments (e.g., Opera, Operetta, CX7, FlowCam)
- Imaging software skills (e.g., ImageJ, CellProfiler)
- Mammalian cell culture and cell-based assays
- Regulatory guidance familiarity (FDA, ICH, USP)
- Strong communication; ability to multitask and collaborate cross-functionally.
Preferred:
- Analytical method development/qualification/validation/tech transfer for cell therapy
- Stem cell biology; ESC/iPSC-derived therapies
- CGT regulatory filing experience.
Education and Experience:
- PhD (3–5+ yrs) or MS (5+ yrs) or BS/BA (8+ yrs) in Biology/Cell biology/Biochemistry or related; proven imaging-based assay expertise; imaging optimization; assay transfer to automated platforms/QC desirable.
Pay Range: $122,400 - $183,600
Flex: On-site (five days/week) with ad hoc flexibility.
Senior Scientist to join the Analytical Development team to develop, optimize, and transfer imaging-based assays to automation platforms or QC environments.
Key Duties and Responsibilities:
- Assay Development: Design, develop, optimize, and qualify/validate imaging-based assays to support drug development and manufacturing; evaluate/implement advanced imaging technologies to improve sensitivity, specificity, and throughput; develop robust, reproducible quantitative image analysis methods.
- Technology Transfer: Lead transfer of imaging-based assays to automation platforms or QC environments with regulatory/industry compliance; collaborate with automation, QA, and manufacturing to implement assays; provide technical support and training to QC teams.
- Data Analysis and Interpretation: Analyze and interpret complex imaging data; develop and qualify/validate imaging data analysis pipelines and algorithms.
- Documentation and Compliance: Author/review protocols, reports, and SOPs; ensure compliance with FDA, ICH, USP, and internal quality standards.
- Collaboration and Leadership: Serve as SME; mentor/train junior scientists; collaborate with research, process development, and QA.
Required Knowledge/Skills:
- Analytical development for biologics, cell, and genetic therapy products
- Image-based assay expertise (IHC, IF)
- Confocal microscopy and high-throughput imaging instruments (e.g., Opera, Operetta, CX7, FlowCam)
- Imaging software skills (e.g., ImageJ, CellProfiler)
- Mammalian cell culture and cell-based assays
- Regulatory guidance familiarity (FDA, ICH, USP)
- Strong communication; ability to multitask and collaborate cross-functionally.
Preferred:
- Analytical method development/qualification/validation/tech transfer for cell therapy
- Stem cell biology; ESC/iPSC-derived therapies
- CGT regulatory filing experience.
Education and Experience:
- PhD (3–5+ yrs) or MS (5+ yrs) or BS/BA (8+ yrs) in Biology/Cell biology/Biochemistry or related; proven imaging-based assay expertise; imaging optimization; assay transfer to automated platforms/QC desirable.
Pay Range: $122,400 - $183,600
Flex: On-site (five days/week) with ad hoc flexibility.