Analytical Development Senior Research Scientist, Imaging Assay Development

Job Description

General Summary:

We are seeking a highly motivated and experienced Senior Scientist to join our Analytical Development team. The successful candidate will play a critical role in the development, optimization, and transfer of imaging-based assays to automation platforms or quality control (QC) environments. This position requires a strong background in analytical development, imaging technologies, and assay automation, as well as a proven ability to work collaboratively in a cross-functional team environment.

Key Duties and Responsibilities:

• Assay Development:

  • Design, develop, optimize, qualify/validate imaging-based assays to support drug development and manufacturing processes.
  • Evaluate and implement advanced imaging technologies to enhance assay sensitivity, specificity, and throughput.
  • Develop robust and reproducible methods for quantitative image analysis.
• Technology Transfer:
  • Lead the transfer of imaging-based assays to automation platforms or QC environments, ensuring compliance with regulatory requirements and industry standards.
  • Collaborate with cross-functional teams, including automation engineers, quality assurance, and manufacturing, to ensure seamless assay implementation.
  • Provide technical support and training to QC teams for assay execution and troubleshooting.
• Data Analysis and Interpretation:
  • Analyze and interpret complex imaging data to support decision-making in product development and quality control.
  • Develop and qualify/validate data analysis pipelines and algorithms for imaging-based assays.
• Documentation and Compliance:
  • Author and review technical documents, including protocols, reports, and standard operating procedures (SOPs).
  • Ensure compliance with regulatory guidelines (e.g., FDA, ICH, USP) and internal quality standards.
• Collaboration and Leadership:
  • Act as a subject matter expert (SME) for imaging-based assays within the organization.
  • Mentor and train junior scientists and research associates.
• Collaborate with cross-functional teams, including research, process development, and quality assurance, to support project goals.

Knowledge and Skills:

Required:

• Understanding of analytical development for biologics, cell and genetic therapy products
• Image-based assay expertise: IHC, IF
• Experience or knowledge in confocal microscopy, and image-based high throughput instruments (e.g. Opera, Operetta, CX7 and FlowCam)
• Strong knowledge of imaging technologies, image acquisition, and analysis software (e.g., ImageJ, CellProfiler, or similar tools).
• Technical expertise in mammalian cell culture, and cell based assays.
• Ability to multi-task as necessary, managing competing priorities and advancing multiple projects within required timelines
• Strong communication skills and a willingness to reach out across teams to accomplish program goals
• Familiar with regulatory (FDA, ICH, USP, etc) guidance surrounding analytical assay development for cell based assays.
• Experience working collaboratively across teams to achieve analytical development goals
• Participation on global development teams(s) where contributions are made to form CMC strategy is preferred

Preferred:

• Strong background in analytical method development, qualification, validation and tech transfer for cell therapy product.
• A background in stem cell biology, experience with stem cell (ESC, iPSC) derived cell therapy product.
• Familiar with regulatory guidance and experience with regulatory filing for CGT products

Other: Flexible team player excited to collaborate with internal and external partners.

Education and Experience:

• Ph.D. in Biology, Cell biology, Biochemistry or a related field with 3-5+ years of relevant industry experience, or M.S. with 5+ years of relevant industry experience, or a BS/BA with 8+ years of relevant industry experience.
• Proven expertise in developing and optimizing imaging-based assays (e.g., fluorescence microscopy, high-content imaging, or other imaging modalities).
• Experience with assay transfer to automated platforms or QC environments is highly desirable.
• Preferred: 3+ years of relevant industry experience in the cell and gene therapy analytical assay development.

Pay Range:

$122,400 - $183,600

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this jo