Associate Director, Analytical Development, Biologics

Role Summary

Associate Director, Analytical Development, Biologics leads Biologic CMC analytical development activities within the Analytical Development Team. The role focuses on advancing biologics projects through internal and external networks, partnering with external labs, and driving analytical development from discovery to regulatory filings and beyond. The position requires strong communication, external collaboration management, and expertise in state-of-the-art analytical methodologies for biologics.

Responsibilities

• Leads an analytical matrix team in execution of biologics analytical development
• Partner with internal and external labs to design, plan, and execute analytical activities leading to IND/IMPD and/or BLA/MAA submissions
• Author CMC sections of regulatory submissions and ensure all work/documents conform to GMP standards
• Proactive resource planning to align with development strategy
• Maintain a strong internal and external network for execution of analytical activities

Qualifications

• Excellent communication and interpersonal skills with the ability to build cross-functional relationships and convey complex issues
• Track record in leading cross-functional matrix teams
• Strong problem-solving skills in biologics development
• Deep technical understanding of analytical methodologies (e.g., LC, iCE, CE-SDS, ELISA, PCR, particulates)
• Expertise in analytical method validation and transfer, analytical control strategy, stability programs, and comparability studies
• Experience authoring CMC sections of regulatory documents and familiarity with regulatory guidelines for biologics
• Knowledge of cGMP requirements
• Strategic thinker with results orientation and urgency to deliver quality results ethically and professionally
• Ability to operate in a dynamic, fast-paced, matrix environment and manage multiple project timelines

Education

• 6-8+ years (PhD) or 9+ years (MS) in analytical, biochemistry, molecular biology, biotechnology, or related field with progressive leadership experience in biotech; experience in analytical control strategy development and biological product CMC development is critical