Senior Director, MS&T

EPM Scientific; Durham (NC); On-site; USD 180,000 - 260,000; Full time

Job summary

EPM Scientific is seeking a Director/Senior Director of Manufacturing Science & Technology to lead tech transfer, process validation, process engineering, and manufacturing support at a large-scale biologics facility.

You will supervise a multidisciplinary team, partnering with Process Development, Manufacturing, Quality, and Facilities to ensure robust cGMP production and successful product commercialization.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical field with significant industry experience; advanced degree preferred.
• Extensive experience in biologics manufacturing, with expertise in either upstream or downstream processing.
• Proven leadership experience in Manufacturing Science & Technology, Process Engineering, Technical Operations, or related disciplines.
• Strong background in technology transfer, process validation, scale-up, process optimization, and commercial manufacturing support.
• Experience working cross-functionally with Process Development, Manufacturing, Quality, Engineering, and Supply Chain.
• Thorough knowledge of cGMP regulations, validation principles, regulatory inspections, and industry standards.
• Experience supporting commercial manufacturing operations in a regulated biopharmaceutical environment.
• Demonstrated ability to lead teams, drive strategic initiatives, and influence organizational decision-making.

Responsibilities

• Lead the introduction of new commercial products, including PPQ, CPV, and inspection readiness activities.
• Support the transfer of clinical and commercial manufacturing processes from development into production environments.
• Establish and maintain systems, procedures, and governance for technology transfer and manufacturing readiness.
• Develop scalable MS&T strategies and technical standards to support growth and consistency.
• Partner with Manufacturing, Quality, Supply Chain, and Engineering to ensure compliant cGMP production and project execution.
• Drive technical initiatives focused on process robustness, efficiency, cost optimization, and risk mitigation.
• Provide strategic leadership for manufacturing support activities, facility expansions, technology implementations, and continuous improvement.
• Build, develop, and retain high-performing scientific and engineering teams.
• Represent MS&T during audits, inspections, client interactions, and leadership reviews.
• Lead cross-functional initiatives supporting manufacturing performance, compliance, and business objectives.

Skills

Biologics manufacturing

Tech transfer

Process validation

Leadership

Cross-functional teamwork

cGMP knowledge

Education

Bachelor's degree in Engineering or Life Sciences

MS or PhD preferred

Job description

A growing biopharmaceutical manufacturing organization is seeking a Director or Senior Director of Manufacturing Science & Technology (MS&T) to lead technical transfer, process validation, process engineering, and manufacturing support laboratory functions at a large-scale biologics production facility. This individual will oversee a multidisciplinary team of scientists and engineers while partnering closely with Process Development, Manufacturing, Quality, Supply Chain, Engineering, and Facilities teams to ensure successful product commercialization and operational excellence.

The ideal candidate will bring deep expertise in biologics manufacturing, either upstream or downstream, along with a strong understanding of tech transfer, process validation, cGMP operations, and industry best practices.

Key Responsibilities

• Lead the introduction of new commercial products, including process performance qualification (PPQ), continued process verification (CPV), and inspection readiness activities.
• Support the transfer of clinical and commercial manufacturing processes from development into production environments.
• Establish and maintain systems, procedures, and business processes that enable efficient technology transfer and manufacturing readiness.
• Develop scalable MS&T strategies and technical standards that support growth and operational consistency.
• Partner with Manufacturing, Quality, Supply Chain, and Engineering teams to ensure reliable cGMP production and successful project execution.
• Drive technical initiatives focused on process robustness, operational efficiency, cost optimization, and risk mitigation.
• Provide strategic leadership for manufacturing support activities, facility expansions, technology implementations, and continuous improvement efforts.
• Build, develop, and retain high-performing scientific and engineering teams.
• Represent the MS&T function during audits, inspections, client interactions, and senior leadership reviews.
• Lead cross-functional initiatives that support manufacturing performance, compliance, and business objectives.

Leadership & Technical Responsibilities

• Provide scientific and technical leadership across technology transfer, process validation, process engineering, and manufacturing support activities.
• Guide cross-functional teams through complex development-to-commercialization projects.
• Establish best practices and technical standards for process transfer and lifecycle management.
• Ensure appropriate systems, procedures, and governance are in place to support successful manufacturing operations.
• Communicate effectively with technical teams, operational stakeholders, and executive leadership to drive business priorities.
• Manage multiple projects, timelines, and resources in a fast-paced manufacturing environment.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field with significant industry experience; advanced degree (MS or PhD) preferred.
• Extensive experience in biologics manufacturing, with demonstrated expertise in either upstream or downstream processing.
• Proven leadership experience within Manufacturing Science & Technology, Process Engineering, Technical Operations, or related disciplines.
• Strong background in technology transfer, process validation, scale-up, process optimization, and commercial manufacturing support.
• Experience working cross-functionally with Process Development, Manufacturing, Quality, Engineering, and Supply Chain organizations.
• Thorough knowledge of cGMP regulations, validation principles, regulatory inspections, and industry standards.
• Experience supporting commercial manufacturing operations in a regulated biopharmaceutical environment.
• Demonstrated ability to lead teams, drive strategic initiatives, and influence organizational decision-making.