Director of MS&T, Biologics Platform

Director, Manufacturing Sciences & Technology (MS&T)

Overview

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
• Cross-site and client-facing initiatives

The Director will lead a team of scientists and engineers while driving operational excellence, process robustness, and successful program delivery.

Key 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

Technical Requirements

• Deep expertise in biologics manufacturing and GMP operations
• Strong experience with:
• Tech transfer
• Process validation
• 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

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

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

Environment

• Fast-paced, high-growth setting
• Strong emphasis on client delivery and operational excellence
• Global collaboration across multiple sites

Additional Context

This role is particularly well suited to individuals who have built their careers in high-throughput, multi-client manufacturing environments with complex technology transfer and commercial execution demands, and who thrive in organizations scaling capabilities across sites and modalities.

Call to Action

If you're interested in leading technical strategy, driving manufacturing excellence, and developing high-performing teams in a growing biologics organization, we encourage you to apply.

Notes on your request:

• All direct identifiers (company name, locations, proprietary platforms) have been removed
• The "large-scale CDMO" preference is embedded via:
• "multi-client manufacturing environments"
• "high-throughput… tech transfer and commercial execution"
• "global network / cross-site complexity"