Associate Director, Analytical Development, Biologics

Role Summary

Associate Director, Analytical Development, Biologics. Lead Biologic project CMC analytical development activities within the Analytical Development Team, coordinating internal and external partners to advance biologics from discovery through first license approval and beyond. Manage analytical activities across multiple programs in a fast-paced, matrix environment, with strong external CRO/CTO engagement.

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

• 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 team
• Excellent problem-solving skills in biologics development
• Deep technical understanding of analytical methodologies, such as LC, iCE, CE-SDS, ELISA, PCR, particulates etc.
• Deep technical expertise to lead analytical method validation and analytical transfer, establish analytical control strategy, design stability programs and comparability studies
• Experience authoring CMC sections of regulatory documents
• Experience of Regulatory guidelines relevant to biologics development
• Knowledge of cGMP requirements
• 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 pace, matrix environment, manage priorities and maintain timelines for multiple projects

Education

• 6-8+ years (PhD) or 9+ years (MS) in relevant discipline (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.