Chief Architect, Small Molecule Analytical R&D

ClinLab Solutions Group; Boston (MA); On-site; USD 170,000 - 230,000; Full time

Job summary

ClinLab Solutions Group in Boston, MA is seeking a Lead Analytical Research & Development leader to direct analytical strategy for a portfolio of small molecule programs from pre-clinical through late-stage clinical development. You will oversee method development, validation, transfer, and external collaborations, ensuring regulatory compliance and robust data for filings and product advancement.

The ideal candidate has 12–15+ years in small molecule analytical development, strong leadership,

Qualifications

• 12–15+ years in small molecule analytical development across pharma/biotech.
• Leadership in analytical development across late-stage and registration activities.
• Experience managing analytical teams and external partnerships.
• Strong knowledge of global regulatory requirements and ICH guidelines.
• Experience with lipophilic drug substances and complex formulations.
• Willingness to travel internationally up to 25%

Responsibilities

• Direct analytical strategy and execution for small molecule programs across development stages.
• Develop and implement phase-appropriate analytical methods for drug substances/products.
• Lead analytical lifecycle management, data integrity, and documentation best practices.
• Oversee outsourced analytical development and testing with CROs/Labs.
• Provide technical leadership in method development, validation, and transfer.

Skills

Strategic leadership

Cross-functional collaboration

Analytical development

Data integrity

Regulatory knowledge

Team management

Literature/regulatory writing

International travel

Education

MS or PhD in Analytical/Physical Chemistry

Tools

GC

LC

IC

Chiral separations

UV/Vis

CAD

MS

MS/MS

FIDA,ECD

Job description

ClinLab Solutions Group in Boston, MA is seeking a Lead Analytical Research & Development leader to direct analytical strategy for a portfolio of small molecule programs from pre-clinical through late-stage clinical development. You will oversee method development, validation, transfer, and external collaborations, ensuring regulatory compliance and robust data for filings and product advancement.

The ideal candidate has 12–15+ years in small molecule analytical development, strong leadership,