Director of MS&T, Biologics Platform

About the role

A rapidly growing biologics organization is seeking a Director of Manufacturing Sciences & Technology (MS&T) to provide strategic and technical leadership across GMP drug substance manufacturing. The organization operates a global network of advanced biologics facilities, supporting programs from early clinical through commercial scale across multiple modalities.

This is a high-impact leadership role within a scaling environment, offering strong visibility, client interaction, and the opportunity to influence global manufacturing strategy and execution.

Role Summary

The MS&T function provides technical oversight and subject matter expertise for biologics manufacturing. The team supports process and technology transfer, manufacturing troubleshooting and lifecycle management, technical documentation and compliance, and cross-site and client-facing initiatives.

Responsibilities

• Provide technical leadership for GMP manufacturing and process transfer activities
• Oversee technology transfer from development into manufacturing
• Lead investigations, deviations, CAPAs, and change controls
• Define and execute departmental strategy and priorities
• Manage and develop a team of 2-10 direct reports
• Drive cross-functional collaboration with PD, Manufacturing, QA/QC, Supply Chain, and PM
• Analyze process data and present insights to internal stakeholders and external partners
• Lead process improvements, risk assessments, and root cause investigations
• Support process validation, characterization, and commercial readiness
• Implement LEAN / operational excellence initiatives
• Manage resources across multiple programs and timelines

Requirements

• Deep expertise in biologics manufacturing and GMP operations
• Strong experience with tech transfer, process validation, and commercial manufacturing support
• Participation in regulatory inspections
• Hands-on knowledge of deviation management, CAPAs, and SOPs
• Batch records and technical documentation
• Strong data analysis and statistical interpretation skills
• Familiarity with single-use systems and bioprocess equipment
• Experience with continuous improvement methodologies

Qualifications

Bachelor's + 15+ years, Master's + 12+ years, or PhD + 8+ years in a STEM field

Minimum 5+ years of leadership experience

Demonstrated experience supporting clinical through commercial-stage programs

Leadership Profile

Proven ability to build and develop high-performing teams

Strong communicator with ability to engage both technical and non-technical audiences

Comfortable leading complex, cross-functional discussions

Highly organized and effective in fast-paced, multi-project environments

Collaborative, adaptable, and execution-focused

Environment

Fast-paced, high-growth setting

Strong emphasis on client delivery and operational excellence

Global collaboration across multiple sites