Hiring: CMC Statistics Director Company: Vertex Pharmaceuticals Location: Boston, MA Job Posted Time: 2026-09-13 11:47:34 Employment Type: Hybrid Target Skills & Keywords : Change Management, Machine Learning, Python, R, Regulatory Compliance, Stakeholder Management About the job Experience: •Demonstrated experience supporting CMC development, process validation, manufacturing, quality operations, and regulatory submissions in a pharmaceutical or biotechnology environment •Demonstrated success establishing statistical best practices, governance models, and capability-building programs within regulated environments Required Skills: •This individual will demonstrate Vertex Core Values while fostering a culture of scientific excellence, continuous improvement, innovation, collaboration, and quality. •Partner with Development, Manufacturing, Quality, Regulatory Affairs, and Data & Digital organizations to provide strategic statistical leadership across the CMC lifecycle •Establish and lead the CMC Statistics Center of Excellence, defining standards, governance, methodologies, and best practices for statistical analyses •Provide statistical leadership for process characterization, process optimization, process robustness studies, technology transfer activities, and lifecycle management programs •Actively facilitate and support application of Design of Experiments (DOE) methodologies to support product and process development, optimization, and control strategy development •Develop and implement statistical approaches supporting Process Performance Qualification (PPQ), Continued Process Verification (CPV), Statistical Process Control (SPC), and process capability monitoring •Support analytical method development, qualification, validation, and lifecycle management through statistically sound study design and data analysis •Provide advanced statistical support for stability programs, shelf-life estimation, comparability assessments, and global regulatory submissions Compensation: •$193,100 - $289,700 / year •Flexible work environment (work from home / hybrid options) •This role is eligible for an annual bonus and annual equity awards Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!