Associate Director, Analytical Quality by Design and Platform Analytical Method Lifecycle

Scorpion Therapeutics; Lexington (MA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Director of Analytical Quality by Design (AQbD) and Platform Analytical Method Lifecycle in a biopharma setting. The role focuses on implementing AQbD across development to enhance method robustness, lifecycle management, and regulatory readiness.

The position is hybrid in Lexington, MA, with English fluency required and Japanese as an asset. You will lead method deployment, standardization, and cross-functional collaboration, while supporting

Qualifications

• 15+ years in analytical chemistry or pharma development with a BS.
• 13+ years with an MS.
• 7+ years of industry experience with a PhD.

Responsibilities

• Lead strategic deployment of analytical methods across programs.
• Standardize analytical development and lifecycle practices.
• Oversee method development, validation, transfer, and lifecycle monitoring.
• Collaborate with R&D, QC, QA, Regulatory CMC, MSAT, and external labs.
• Support regulatory submissions and inspections.
• Promote continuous improvement across platforms.

Skills

AQbD workflows

Cross-functional leadership

Analytical method lifecycle

Regulatory readiness

Education

B.S. Analytical Chemistry or related field

M.S. Analytical Chemistry or related field

Ph.D. in related field

Job description

Role

Associate Director of Analytical Quality by Design (AQbD) and Platform Analytical Method Lifecycle in biopharma, focusing on implementing AQbD principles across development to enhance method robustness, lifecycle management, and regulatory readiness.

Responsibilities

• Lead the strategic deployment of analytical methods
• Standardize practices
• Oversee method development, validation, transfer, and lifecycle monitoring
• Collaborate with R&D, QC, QA, Regulatory CMC, MSAT, and external labs
• Support regulatory submissions and inspections
• Promote continuous improvement

Requirements

• BS in Analytical Chemistry, Pharmaceutical Sciences, or related field with 15+ years
• MS with 13+ years
• PhD with 7+ years of industry experience
• Deep expertise in analytical development for small molecules, biologics, or modalities
• Strong knowledge of ICH Q14/Q2(R2), validation, and lifecycle management
• Proven track record in implementing AQbD workflows and cross-functional leadership

High Value

biopharma, analytical development, AQbD, lifecycle management, validation, cross-program standardization, global matrix environment, regulatory compliance, expertise in small molecule or biologics modalities.

Work Setup

hybrid in Lexington, MA; fluent in English, Japanese an asset.