Senior Scientist, Analytical Science & Technology (Remote)

Aurion Biotech Inc.; Seattle, Boston (WA, MA); Hybrid; USD 140,000 - 155,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

EAP and FSA benefits

Generous PTO

Job summary

Aurion Biotech is seeking a Senior Scientist, Analytical Science & Technology to lead method transfers and validations at external CDMOs for late-stage cell therapy programs. The role reports to the Senior Manager, Analytical Science & Technology and requires deep QC, cGMP, and regulatory knowledge, with a focus on ensuring robust analytical capabilities across development stages.

The candidate will drive protocol authoring, data review, and reporting, while collaborating with Analytical

Qualifications

• Experience with method validations and USP method verification.
• Hands-on Flow Cytometry experience.
• Strong knowledge of cGMP, EMA, FDA, ICH guidelines as they relate to QC testing.
• Experience interfacing with CDMOs and external labs.

Responsibilities

• Lead transfers and validations at external CDMOs.
• Author/review protocols, raw data and reports.
• Support QC deliverables for late-stage development.
• Collaborate with Analytical Development, CMC, and QA.
• Develop technical proposals and implement resolutions for challenges.
• Ensure QC methods comply with cGMP and regulatory requirements.
• Provide technical support for deviations and investigations.
• Maintain flexibility as phase-appropriate.

Skills

Interface with CDMOs

Collaboration across functions

Analytical mindset

Written and verbal communication

Project deliverables management

Independent problem solving

Quality mindset

MS Office proficiency

Strong regulatory understanding

Education

Master’s Degree in related field

Bachelor’s Degree in related field

Tools

JMP

MS Office

Job description

Aurion Biotech is seeking a Senior Scientist, Analytical Science & Technology to lead method transfers and validations at external CDMOs for late-stage cell therapy programs. The role reports to the Senior Manager, Analytical Science & Technology and requires deep QC, cGMP, and regulatory knowledge, with a focus on ensuring robust analytical capabilities across development stages.

The candidate will drive protocol authoring, data review, and reporting, while collaborating with Analytical