Senior Scientist, Analytical Development – Cell Therapy

Aurion Biotech; Cambridge (MA); On-site; USD 155,000 - 170,000; Full time

Benefits offered by this job

Full health benefits

401(k) matching

Paid parking

Commuter benefits

Catered lunches

Job summary

Aurion Biotech in Cambridge, MA is seeking a Senior Scientist, Analytical Development to lead analytical method development for cell therapy products. You will work with cross-functional teams to develop, qualify, and transfer assays supporting clinical manufacturing and testing timelines.

The role requires expertise in Flow Cytometry, qPCR/dPCR, ELISA, and GMP documentation, with collaboration across Research, Process Development, Quality, and Manufacturing.

Qualifications

• PhD or MS degree with relevant pharmaceutical experience.
• Experience with analytical method development for cell therapy products.
• Strong background in immunology, biochemistry, or cell biology.
• Track record in regulatory-friendly documentation and data handling.

Responsibilities

• Conduct independent lab experiments (Flow Cytometry, qPCR/dPCR, ELISA, cell counting, potency assays).
• Collaborate cross-functionally with Cell Production, Process Development, Manufacturing, and Quality.
• Authorize method qualification SOPs, qualification reports, and test method SOPs for regulatory submissions.
• Track project milestones and ensure timely deliverables.
• Develop, qualify, and transfer GMP-compliant analytical methods for clinical-stage cell therapy products.
• Train other groups to perform in-house assays.
• Apply QC and regulatory knowledge to late-stage method development and documentation.
• Perform other duties as assigned.

Skills

Flow Cytometry

qPCR

dPCR

ELISA

Cell counting

Analytical development

Regulatory knowledge

Education

PhD in relevant field

MS degree in relevant field

Tools

FlowJo

JMP

GraphPad

Job description

Aurion Biotech in Cambridge, MA is seeking a Senior Scientist, Analytical Development to lead analytical method development for cell therapy products. You will work with cross-functional teams to develop, qualify, and transfer assays supporting clinical manufacturing and testing timelines.

The role requires expertise in Flow Cytometry, qPCR/dPCR, ELISA, and GMP documentation, with collaboration across Research, Process Development, Quality, and Manufacturing.