Biologics Analytics & CMC Statistics Lead

Summit Therapeutics Inc.; Princeton, Northern (NJ, KY); Hybrid; USD 180,000 - 200,000; Full time

Benefits offered by this job

Bonus opportunities

Job summary

Summit Therapeutics Inc. in Princeton, NJ, seeks an Associate Director of Analytical Development & CMC Statistics to lead analytical method development, validation, transfer, and lifecycle management for biologics.

You will partner with MSAT, Quality, Regulatory Affairs, and external CDMOs to ensure robust, regulatory-compliant strategies for global submissions and product readiness. You will apply advanced statistics to stability modeling, comparability, and specification setting, and

Qualifications

• Advanced degree(s) preferred in Statistics, Biostatistics, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering; Bachelor’s or master’s degree with substantial relevant experience will be considered.
• Minimum of 10+ years of relevant experience in biopharmaceutical or pharmaceutical industry, including direct experience supporting CMC analytical development and/or process development and manufacturing activities.
• Strong knowledge of biologics analytical methods, including chromatographic, electrophoretic, immunoassay, potency, binding, impurity, and/or process residuals.
• Experience with analytical method development, validation, method transfer, comparability, specification setting, stability analysis, and statistical analysis & interpretation of CMC datasets.
• Working knowledge of ICH, FDA and EMA guidance and GMP regulation, and data integrity expectations relevant to analytical development and lifecycle management.
• Experience reviewing or authoring protocols, reports, regulatory submission sections, health authority responses, deviations, OOS/OOT investigations, CAPAs, and change controls.
• Travel may be required periodically to support CDMO/CRO oversight, technical meetings, regulatory interactions, or cross-functional workshops.

Responsibilities

• Provide scientific and technical leadership for analytical method development, qualification, validation, transfer, troubleshooting, and lifecycle management for biologic drug substance and drug product programs.
• Support phase-appropriate analytical strategies for release, stability, characterization, comparability, potency, binding, impurity, and residual testing.
• Review and interpret analytical data from CDMOs, CROs, and partner laboratories to ensure methods are robust, fit for purpose, and aligned with regulatory expectations.
• Contribute to analytical control strategy development, including critical quality attribute assessment, method performance monitoring, and product quality trend evaluation.
• Lead statistical planning, analysis, and interpretation for analytical method validation, method transfer, comparability, stability, specification setting, assay qualification, and investigation support.
• Apply appropriate statistical tools to evaluate accuracy, precision, linearity, range, robustness, intermediate precision, equivalence, trending, outliers, assay variability, and method capability.
• Develop and justify statistically sound acceptance criteria, comparability criteria, stability models, DS and DP shelf-life determinations, stability trending approaches, and analytical control limits.
• Partner with CMC, Quality, Regulatory Affairs, and external partners to ensure statistical approaches are scientifically defensible and clearly documented in protocols, reports, and regulatory submissions.
• Support data visualization, multivariate analysis, and trend monitoring to enable early identification of analytical or manufacturing risks.
• Support inspection readiness, audit responses, regulatory commitments, and post-approval lifecycle management activities related to analytical methods, stability, specifications, and comparability.
• Provide statistical input into deviations, OOS/OOT investigations, CAPAs, change controls, and risk assessments.
• Provide analytical and statistical oversight for external CDMOs, CROs, and partner laboratories performing release, stability, characterization, method transfer, method validation, and comparability studies.
• Review external protocols, reports, data packages, deviations, and investigations to ensure technical quality, compliance, and alignment with program objectives.
• Communicate complex analytical and statistical findings clearly to technical and non-technical stakeholders, including senior leadership.
• Contribute to internal SOPs, templates, best practices, and governance processes for analytical development, CMC statistics, and outsourced analytical activities.
• All other duties as assigned.

Job description

Summit Therapeutics Inc. in Princeton, NJ, seeks an Associate Director of Analytical Development & CMC Statistics to lead analytical method development, validation, transfer, and lifecycle management for biologics.

You will partner with MSAT, Quality, Regulatory Affairs, and external CDMOs to ensure robust, regulatory-compliant strategies for global submissions and product readiness. You will apply advanced statistics to stability modeling, comparability, and specification setting, and