Field Development Manager (Late Phase CMC/BLA)

Field Development Manager – Late Stage CMC & BLA Readiness

About the Company

Our client is a global life sciences analytical services organization delivering comprehensive chemistry, manufacturing, and controls (CMC) solutions to pharmaceutical and biotechnology companies. With approximately 500–1,000 employees and annual revenues in the range of $150M–$300M, the organization operates across North America, Europe, and Asia-Pacific through multiple centers of scientific excellence.

The company supports development programs across small molecules, biologics, and advanced therapies, providing end-to-end analytical and regulatory expertise from early development through commercialization. All operations adhere to the highest quality and compliance standards, including GMP, GLP, ISO, and global regulatory requirements.

Position Overview

We are partnered with a leading global CMC analytics provider to identify a Field Development Manager – Late Stage CMC & BLA Readiness. This role is designed for a seasoned CMC professional who excels in guiding biologics programs through late-stage development, licensure preparation, and regulatory submission.

The Field Development Manager will act as a strategic scientific advisor to pharmaceutical and biotech clients, integrating analytical execution, regulatory expectations, and risk mitigation to support successful BLA submissions, PPQ readiness, and inspection success. A major focus of the role includes leadership of Extractables and Leachables (E&L) strategy, along with method robustness, comparability, and global market entry considerations.

This position blends deep technical expertise with customer-facing leadership and cross-functional collaboration in a highly visible, strategic role.

Key Responsibilities

• Serve as the primary scientific lead for late-stage CMC and BLA readiness programs
• Guide analytical strategy across validation, stability, release testing, and PPQ execution
• Lead Extractables & Leachables (E&L) risk assessments and regulatory strategy
• Drive comparability, method robustness, and post-approval lifecycle planning
• Translate regulatory expectations into executable project strategies
• Collaborate across scientific, quality, and commercial teams to ensure submission success

Company & Opportunity Differentiators

• Recognized global leader in high-complexity CMC analytics and regulatory support
• Deep expertise supporting biologics through late-stage development and licensure
• Strong track record in BLA readiness, PPQ execution, and inspection success
• High-impact consultative role influencing critical development milestones
• Exposure to advanced therapeutic modalities and global regulatory strategy
• Collaborative, science-driven culture integrating technical excellence with commercial strategy
• Opportunity to shape client programs rather than operate in a transactional service model