Associate Director, Analytical Development & CMC Statistics

Overview of Role:

The Associate Director of Analytical Development and CMC Statistics will provide technical and statistical leadership for analytical development, method validation, method transfer, comparability, stability, specifications, and lifecycle management activities supporting biologic drug substance and drug product programs. This role will sit within the CMC Analytical Sciences organization and will partner closely with Analytical, MSAT, Quality, Regulatory Affairs, Supply Chain, and external CDMOs/CROs to ensure that analytical strategies, statistical approaches, and data packages are scientifically robust, phase-appropriate, compliant, and suitable for global regulatory submissions and commercial readiness.

The successful candidate will combine hands-on experience in biologics analytical development with strong statistical expertise, including method validation statistics, stability and shelf-life modeling, specification setting, comparability assessments, assay lifecycle monitoring, and statistical support for CMC investigations. This individual will be expected to translate complex analytical datasets into clear conclusions, support risk-based decision-making, and contribute directly to IND/IMPD, BLA/MAA, post-approval, and health authority response activities.

Role and 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.

Experience, Education and Specialized Knowledge and Skills:

• Advanced degree(s) preferred in Statistics, Biostatistics, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline; Bachelor's or master's degree with substantial relevant experience will be considered.
• Minimum of 10+ years of relevant experience in the biopharmaceutical or pharmaceutical industry, including direct experience supporting CMC analytical development and/or process development and manufacturing activities.
• Strong knowledge and understanding of biologics analytical methods, including chromatographic, electrophoretic, immunoassay, potency, binding, impurity, and/or process residuals.
• Demonstrated 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, as well as 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.