Analytical Development, Associate Director Biologics

Role Summary

Vertex is seeking a talented and experienced leader to join the Analytical Development Team to lead Biologic project CMC analytical development activities. The leader will play a central role in advancing biologics projects by executing development activities through an internal and external network, and will closely collaborate with external partners to progress from discovery through first license approval and beyond. The role requires leading analytical activities in alignment with phase-appropriate development strategies and working in a fast-paced, matrix environment with strong external collaboration management.

Responsibilities

• Leads an analytical matrix team in execution of biologics analytical development
• Partnering with internal and external labs in executing analytical development activities, including designing, planning, and executing all analytical activities that lead to successful IND/IMPD and/or BLA/MAA applications.
• Authors CMC sections of regulatory submissions. Ensures that all regulated work and documents conform to GMP standards
• Proactive resource planning to align with established development strategy
• Maintain a strong internal and external network for the execution of analytical activities

Qualifications

• Experience authoring CMC sections of regulatory documents.
• Experience with regulatory guidelines relevant to biologics development.
• Knowledge of cGMP requirements.

Skills

• Excellent communication skills and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts
• Track record in leading cross-functional matrix teams
• Excellent problem-solving skills in biologics development
• Deep technical understanding of analytical methodologies, such as LC, iCE, CE-SDS, ELISA, PCR, particulates
• Deep technical expertise to lead analytical method validation and analytical transfer, establish analytical control strategy, design stability programs and comparability studies
• A strategic thinker with a strong result orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
• The ability to work in a dynamic, fast-paced matrix environment, manage priorities and maintain timelines for multiple projects

Education

• 6-8+ years (PhD) or 9+ years (MS) in analytical, biochemistry, molecular biology, biotechnology or related field with progressive experience in technical leadership roles in the biotech industry, and specifically in the development of analytical control strategies. Experience with Biological products CMC development is critical