Analytical Development Senior Research Scientist, Imaging Assay Development

Senior Scientist (Analytical Development)

Responsibilities:
- Design, develop, optimize, and qualify/validate imaging-based assays to support drug development and manufacturing.
- Evaluate and implement advanced imaging technologies to improve sensitivity, specificity, and throughput.
- Develop quantitative, robust and reproducible methods for image analysis.
- Lead technology transfer of imaging-based assays to automation platforms or QC environments while ensuring regulatory compliance.
- Collaborate with automation, QA, and manufacturing; provide QC technical support and training.
- Analyze complex imaging data; develop and qualify/validate data analysis pipelines and algorithms.
- Author/review technical documents (protocols, reports, SOPs) and ensure compliance (FDA/ICH/USP).
- Serve as SME; mentor junior scientists and support cross-functional project goals.

Required skills/qualifications:
- Analytical development understanding for biologics, cell & genetic therapy products.
- Image-based assay expertise (IHC, IF).
- Confocal microscopy and high-throughput imaging instrument experience (e.g., Opera/Operetta/CX7/FlowCam).
- Imaging software skills (e.g., ImageJ, CellProfiler or similar).
- Mammalian cell culture and cell-based assay expertise.
- Strong communication; ability to manage competing priorities.

Preferred:
- Analytical method development/qualification/validation/tech transfer for cell therapy.
- Stem cell biology experience (ESC/iPSC) and CGT regulatory guidance/filing experience.

Education/experience:
- Ph.D. (3–5+ yrs), or M.S. (5+ yrs), or BS/BA (8+ yrs) in related field; proven imaging-based assay development.

Pay range: $122,400–$183,600. Eligible for annual bonus and annual equity awards.