Senior Scientist, Analytical Science & Technology - Remote

Aurion Biotech; Washington; Remote; USD 140,000 - 155,000; Full time

Benefits offered by this job

Full health insurance

401(k) matching

PTO & benefits

Job summary

Aurion Biotech is seeking a Senior Scientist, Analytical Science & Technology, for a remote US-based role. You will lead method transfers and validations at external CDMOs, review data, and author reports, ensuring alignment with cGMP and regulatory standards.

Applicants located in WA or MA preferred; other eligible states include IN, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, WI, MS. Strong collaboration with internal stakeholders is essential.

Qualifications

• 8+ years in QC or related function with advanced degree (Master/PhD) or 8+ years with a Bachelor's.
• Experience with method validations and USP method verification in late-stage development.
• Excellent knowledge of cGMP, pharmacopeial guidelines (EMA, FDA, ICH) relevant to QC testing.

Responsibilities

• Lead all QC method transfers and validations at external CDMOs.
• Review outsourced GMP work and serve as Lead SME for validations and USP equivalency testing.
• Build tools to monitor assay validity and assess trends; maintain documentation.
• Interface with CMOs and internal teams (Analytical Development, CMC, QA).
• Provide technical support for deviations and investigations; manage change requests.

Skills

Quality Control

Method validations

cGMP compliance

Flow Cytometry

Statistical analysis (JMP)

Cross-functional collaboration

Education

Master’s Degree or PhD with QC experience

Bachelor’s Degree

Tools

JMP

Job description

Aurion Biotech is seeking a Senior Scientist, Analytical Science & Technology, for a remote US-based role. You will lead method transfers and validations at external CDMOs, review data, and author reports, ensuring alignment with cGMP and regulatory standards.

Applicants located in WA or MA preferred; other eligible states include IN, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, WI, MS. Strong collaboration with internal stakeholders is essential.