Analytical Scientist, CMC

Scorpion Therapeutics; Durham (NC); On-site; USD 130,000 - 180,000; Full time

Job summary

Scorpion Therapeutics in Durham, NC is seeking a Hands-on Analytical Scientist in CMC for gene therapy programs. This onsite role focuses on developing and qualifying analytical methods, cell-based potency assays, and data review to support regulatory submissions.

The candidate will work with R&D, Quality, and Regulatory teams, applying GMP/ICH practices and contributing to stability and characterization activities for retinal disease programs.

Qualifications

• B.S./M.S. in Biochemistry, Molecular Biology, Analytical Chemistry, or related field.
• 4+ years in analytical development or QC in biotech/pharma.
• Hands-on experience with AAV gene therapies and analytical techniques.

Responsibilities

• Develop, qualify, transfer, troubleshoot analytical methods (identity, purity, potency, safety, stability).
• Perform cell-based potency assays and bioanalytical tests (qPCR/ddPCR, ELISA, HPLC/UPLC).
• Review external data and author technical documents.
• Support regulatory submissions.
• Collaborate across R&D, Quality, Regulatory.

Skills

Analytical development

Quality control

Technical writing

qPCR/ddPCR

AAV assays

Education

B.S./M.S. in Biochemistry

Molecular Biology

Analytical Chemistry

Tools

HPLC/UPLC

ELISA

qPCR/ddPCR

GMP

CDMO management

Job description

Role

Hands‑on Analytical Scientist in CMC for gene therapy programs at a clinical‑stage biotech focused on retinal diseases.

Responsibilities

• develop, qualify, transfer, troubleshoot analytical methods (identity, purity, potency, safety, stability)
• perform cell‑based potency assays and bioanalytical tests (qPCR/ddPCR, ELISA, HPLC/UPLC)
• review external data
• author technical documents
• support regulatory submissions
• contribute to stability and characterization activities
• collaborate across R&D, Quality, Regulatory

Requirements

• B.S./M.S. in Biochemistry, Molecular Biology, Analytical Chemistry, or related
• 4+ years in analytical development or QC in biotech/pharma
• hands‑on experience with AAV gene therapies and analytical techniques
• managing CRO/CDMO activities
• familiarity with GMP, ICH, FDA standards
• strong technical writing

Preferred

• ophthalmology/ocular gene therapy background
• startup experience

WorkSetup

onsite Durham, NC; local candidates strongly preferred; salary $130K-$180K.