Senior Director, Analytical Development & Lab Automation

Vertex Pharmaceuticals Incorporated; Boston (MA); Presencial; USD 226 000 - 339 000; Tempo integral

Resumo da oferta

Vertex Pharmaceuticals Incorporated is seeking a Senior Director of Analytical Development to lead testing strategy, automation, and informatics across cell, gene, and biologic programs. The role drives process characterization, supports development, and shapes cross-functional analytical capabilities.

You will mentor teams, manage budgets, and advance digital platforms for data interpretation while ensuring compliance with ICH, FDA, and USP guidelines.

Qualificações

• Masters or PhD with leadership in pharma analytical development.
• 11+ years post-doctoral experience or 15+ years depending on degree.
• Cell Therapy, Biologics, and Genetic therapies experience is critical.
• Experience in process development and stability studies is desired.

Responsabilidades

• Provide strategic leadership for Testing, Operations, and Automation Analytical Development across programs.
• Establish and drive testing strategies using manual and automated methods for process development and stability studies.
• Lead and oversee teams for automated and PAT analytical methods and end-to-end automation platforms.
• Lead laboratory informatics and digitization projects supporting data trending and visualization, including AI/ML tools.
• Establish and manage assay reagents, controls, and control charts for optimal performance.
• Maintain best practices in sampling, data management, integrity, notebooks, documentation, and training.
• Build cross-functional/external partnerships to advance goals.
• Author and review study protocols, reports, methods, and regulatory documentation.
• Recruit, mentor, and develop talent while managing resources and budgets.

Conhecimentos

Analytical testing leadership

Laboratory informatics

AI/ML in lab automation

Digitization and data visualization

Regulatory knowledge (ICH, FDA, USP)

Project and people leadership

Formação académica

Masters or PhD in analytical sciences or related field

Ph.D. and 11+ years relevant post-doctoral experience

Masters and 15+ years relevant employment experience

Ferramentas

Laboratory informatics platforms

Descrição da oferta de emprego

Vertex Pharmaceuticals Incorporated is seeking a Senior Director of Analytical Development to lead testing strategy, automation, and informatics across cell, gene, and biologic programs. The role drives process characterization, supports development, and shapes cross-functional analytical capabilities.

You will mentor teams, manage budgets, and advance digital platforms for data interpretation while ensuring compliance with ICH, FDA, and USP guidelines.