Associate Director, Technical Operations Quality Control

Scorpion Therapeutics; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks an Associate Director, Technical Operations QC to oversee QC activities for small molecule drug products in rare disease development, ensuring GMP and regulatory compliance.

The role requires leadership over QC for drug substance and product manufacturing, method transfer, stability programs, and investigations of OOS/OOT results with support for regulatory submissions and vendor audits.

Qualifications

• Bachelor's in Chemistry, Biochemistry, or related field.
• 8+ years in analytical operations, development, or QC within biotech/pharma.
• Experience with biologics and small molecules.

Responsibilities

• Lead QC support for drug substance and product manufacturing at CMOs.
• Oversee specifications, batch release, and stability programs.
• Provide scientific support for testing, stability studies, method transfer, regulatory submissions, and change assessments.
• Manage investigations of OOS/OOT results and vendor audits.

Skills

QC leadership

HPLC

GC

MS

NMR

GMP

Regulatory knowledge

OOS investigations

CMC collaboration

Education

Bachelor's in Chemistry/Biochemistry

MS or higher degree

Tools

Veeva

Job description

Role

Associate Director, Technical Operations QC, overseeing QC activities for small molecule drug products in rare disease development, ensuring GMP and regulatory compliance.

Responsibilities

• lead QC support for drug substance and product manufacturing, oversee specifications, batch release, and stability programs at CMOs; provide scientific support for testing, stability studies, method transfer, regulatory submissions, and process change assessments; manage investigations of OOS/OOT results and support vendor audits.

Requirements

• Bachelor's in Chemistry, Biochemistry, or related; 8+ years in analytical operations, development, or QC within biotech/pharma, with experience in biologics and small molecules; expertise in analytical methods such as HPLC, GC, MS, NMR; knowledge of GMP and regulatory standards (FDA, ICH, EU).

Preferred

• MS or higher degree, late-stage drug development experience, familiarity with Veeva.

High-Value

• rare disease focus, small molecule drugs, GMP environment, regulatory compliance, stability, and quality control leadership.

Collaboration

• work closely with Analytical, CMC, Regulatory, and Manufacturing teams.

WorkSetup

• Remote with 10-20% travel, face-to-face work in San Diego as needed.