Director/Senior Director, Analytical Services (Separations & External Laboratories)

Scorpion Therapeutics; United States; On-site; USD 180,000 - 260,000; Full time

Job summary

Scorpion Therapeutics seeks a Lead to provide technical and operational oversight of external laboratories supporting commercial biologics, focusing on separations assays for monoclonal antibodies. The role ensures assay robustness and vendor performance across global partners.

You will manage CDMOs/CROs, drive CAPAs, communicate technical, quality, and regulatory matters, and support regulatory submissions and investigations.

Qualifications

• 15+ years industry experience.
• Deep expertise in separations for biologics (especially mAbs).
• Proven success managing CDMOs/CROs.
• Strong communication skills.

Responsibilities

• Ensure assay robustness.
• Evaluate vendor performance.
• Troubleshoot complex issues.
• Drive corrective actions.
• Build and maintain strong vendor partnerships.
• Communicate technical, quality, and regulatory matters effectively.
• Support regulatory submissions and investigations.

Skills

Separation science (biologics)

CDMOs/CDROs management

Strong communication

Job description

Role: Lead technical and operational oversight of external laboratories supporting commercial biologics, focusing on separations assays for mAbs.

Responsibilities

• ensure assay robustness
• evaluate vendor performance
• troubleshoot complex issues
• and drive corrective actions
• build and maintain strong vendor partnerships
• communicate technical, quality, and regulatory matters effectively
• support regulatory submissions and investigations

Requirements

• 15+ years industry experience
• deep expertise in separations for biologics (especially mAbs)
• proven success managing CDMOs/CROs
• strong communication skills

HighValue

• extensive biologics experience with commercial-stage products
• GMP analytical testing
• regulatory support
• vendor performance management

WorkSetup: travel required; full-time U.S. based, no visa sponsorship.