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:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at