Associate Director, Biologics Analytics & CMC Statistics

Summit Therapeutics, Inc.; Princeton (NJ); On-site; USD 180,000 - 200,000; Full time

Job summary

Summit Therapeutics Inc. in Princeton, NJ, is seeking an Associate Director of Analytical Development and CMC Statistics to lead analytical method development, qualification, validation, transfer and lifecycle management for biologic drug substances and drug products.

This role collaborates with CMC, Quality, Regulatory Affairs and external CDMOs/CROs to ensure scientifically robust statistics, data interpretation, and regulatory readiness for IND/IMPD, BLA/MAA, and post‑approval activities.

Qualifications

• Advanced degree(s) in Statistics, Biostatistics, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• Minimum of 10+ years in the biopharmaceutical industry with CMC analytical development exposure.
• Experience with analytical method development, validation, transfer, comparability, stability, and regulatory submissions.

Responsibilities

• Provide scientific and statistical leadership for analytical method development, qualification, validation, transfer, and lifecycle management.
• Support release, stability, characterization, comparability, and impurity testing strategies.
• Review data from CDMOs/CROs to ensure methods are robust, fit for purpose, and regulatory-aligned.
• Lead statistical planning and interpretation for validation, transfer, comparability, and stability.
• Develop acceptance criteria, stability models, and analytical control strategies.
• Collaborate with CMC, Quality, Regulatory Affairs, and external partners for regulatory readiness and inspection support.

Skills

Statistics

Biostatistics

Analytical chemistry

GMP knowledge

Regulatory science

Education

Advanced degree in Statistics/ Biostatistics/ Analytical Chemistry

Job description

Summit Therapeutics Inc. in Princeton, NJ, is seeking an Associate Director of Analytical Development and CMC Statistics to lead analytical method development, qualification, validation, transfer and lifecycle management for biologic drug substances and drug products.

This role collaborates with CMC, Quality, Regulatory Affairs and external CDMOs/CROs to ensure scientifically robust statistics, data interpretation, and regulatory readiness for IND/IMPD, BLA/MAA, and post‑approval activities.