Biologics MS&T Senior Director: Tech Transfer & Scale-Up

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

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.