Vaxcyte

Director

• Serve as the CMC statistical lead for the VSWG, supporting specification-setting strategy for drug substance, drug product, intermediates, raw materials, release testing, stability testing, and in-process testing.
• Develop statistical strategies for specification and JOS using clinical experience, manufacturing experience, stability behavior, analytical variability, assay capability, and process capability.
• Design and execute statistical analyses such as confidence intervals, prediction intervals, tolerance intervals, regression, ANOVA, DOE, equivalence testing, trend analysis, control charts, and Cpk/process capability analyses.
• Provide statistical input to late-stage development, PPQ, BLA/MAA preparation, health authority responses, commercial readiness, and specification lifecycle management.
• Author and review statistical sections of specification and JOS documents, CMC technical reports, regulatory submission sections, and briefing materials.
• Assess analytical method performance and method lifecycle changes, including precision, transfer/bridging, comparability, and impact of analytical variability on specification decisions.
• Partner with Process Development, MSAT, Stability, QA, RA, Manufacturing, and external partners to align statistical rationale with CMC control strategy and regulatory expectations.
• Support PPQ, APR, and CPV activities by evaluating process consistency, state of control, trends, internal control limits, and capability relative to proposed or registered specifications.
• Translate complex statistical concepts into clear recommendations for cross-functional teams, senior leaders, and non-statistical stakeholders; support audits, inspections, and health authority interactions as needed.

Associate Director, CMC Statistician

Manager

• Serve as the technical expert for QC microbiological assays.
• Support the authoring and review internal SOPs related to microbial Quality Control policies and procedures.
• Responsible for quality event management related to microbiology QC and aseptic manufacturing operations.
• Manage outsourced cGMP and characterization testing supporting lot release.
• Collaborate with Analytical Development, Quality Control, and Product Development and interface with key stakeholders.
• Apply technical and compliance expertise to the review of test methods and provide feedback.
• Work with others to identify opportunities for continuous improvement and implement solutions.
• Provide strong teamwork in establishing a quality culture and shared accountability.

Associate Director, CMC Statistician

Senior Manager, Microbiology Support – Global ASAT