Associate Director, Biologics Analytics & CMC Statistics

Socket.dev; Princeton (NJ); On-site; USD 180,000 - 200,000; Full time

Job summary

Summit Therapeutics Inc. seeks an Associate Director of Analytical Development and CMC Statistics to lead analytical development, method validation, and lifecycle management for biologic programs.

You will partner across Analytical, MSAT, Quality, Regulatory Affairs, and external CDMOs/CROs to ensure robust strategies for global regulatory submissions and commercial readiness. The role combines hands-on biologics analytical development with strong statistical expertise, supporting IND/IMPD,

Qualifications

• Minimum 10+ years in biopharmaceuticals with experience supporting CMC analytical development
• Strong knowledge of biologics analytical methods and regulatory expectations (ICH, FDA, EMA)
• Experience with protocols, regulatory submissions, deviations, CAPAs, and change controls

Responsibilities

• Provide scientific and technical leadership for analytical method development, qualification, validation, transfer, troubleshooting, and lifecycle management for biologic programs.
• Support release, stability, characterization, comparability, potency, impurity, and residual testing.
• Review data from CDMOs/CROs to ensure methods are robust and fit for regulatory purposes.
• Lead analytical strategy development, including CQAs, method performance monitoring, and trending.
• Provide statistical planning and interpretation for validation, transfer, comparability, and stability.
• Develop acceptance criteria and comparability criteria, stability models, and shelf-life determinations.
• Collaborate with CMC, Quality, Regulatory Affairs, and external partners to document statistical approaches for submissions.
• Communicate complex findings to leadership and contribute to SOPs and governance.

Skills

Statistical leadership

Analytical development

Biologics analytics

Method validation

Regulatory submissions

Data visualization

Education

Advanced degree in Statistics/Biostatistics/Analytical Chemistry

Experience with biologics analytical development

Job description

Summit Therapeutics Inc. seeks an Associate Director of Analytical Development and CMC Statistics to lead analytical development, method validation, and lifecycle management for biologic programs.

You will partner across Analytical, MSAT, Quality, Regulatory Affairs, and external CDMOs/CROs to ensure robust strategies for global regulatory submissions and commercial readiness. The role combines hands-on biologics analytical development with strong statistical expertise, supporting IND/IMPD,