Director of MS&T, Biologics Platform

About the Role

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. 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, and 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

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.