Director of MS&T, Biologics Platform
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Role details
Tech stack
Job description
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., * 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
Do you have experience in Technology transfer (scale-up process)?, Do you have a Master’s degree?, + 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, * 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., 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.
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