Senior Director, Biological Analytical Development

Role Summary

The Senior Director, Biological Analytical Development is responsible for providing both leadership and hands-on technical expertise for analytical aspects of biologic CMC programs. This role combines strategic oversight with direct scientific contributions ensuring delivery of high-quality methods, specifications, and regulatory documentation to enable clinical development and regulatory submissions. The role can manage a team as well as external partners/CMOs, balancing mentorship and oversight with active participation in experimental design, data interpretation, and issue resolution.

Responsibilities

• Provide scientific and operational leadership of biological analytical development activities from early stage through validation and transfer to QC.
• Act as both leader and contributor: oversee external partners and direct reports, while also engaging in hands-on work such as reviewing data, drafting regulatory sections, and troubleshooting technical issues.
• Define and implement phase-appropriate analytical strategies for biologics drug substance, drug product, intermediates, and critical components.
• Oversee method scouting, qualification, validation and tech transfer in accordance with appropriate regulatory requirements
• Ensure robust stability programs, reference standards, and specifications are developed and maintained.
• Conduct and/or oversee characterization studies, comparability assessments, and product risk assessments.
• Support and mentor a team of scientists; provide coaching while contributing directly to program deliverables.
• Manage interactions with CDMOs and testing labs, ensuring timelines and quality standards are met.
• Draft and review regulatory documents (IND, IMPD, BLA/MAA) and contribute to agency meeting preparations.
• Partner with Regulatory CMC, Quality, and other functions to ensure compliance with global regulations.
• Participate in the Analytical Development Leadership Team and contribute to strategy setting across modalities.

Qualifications

• At least 10 years of hands-on experience in biologics analytical development and method validation (previous managerial experience a plus) for Analytical Development from Phase 1 to approval.
• Experience in characterization of biologics and in generating data analysis reports for Reg filings and Analytical Comparability Assessments
• Experience managing contract development
• Experience in addressing regulatory queries and authoring analytical sections of IND/IMPD or BLA/MAA.
• Preferred: Experience leading a CMC Development Team
• Demonstrates technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills.
• Excellent written and verbal communication skills.

Education

• The position requires a B.Sc. or M.Sc. in Analytical Chemistry/Science/Biotechnology/Science/Engineering or related field

Additional Requirements

• Travel: Occasional domestic and international travel to visit contractors for project reviews or to support ongoing development.