Director, Biopharma Manufacturing Science & Tech

ClinLab Solutions Group; Morrisville (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

ClinLab Solutions Group seeks a Director of Formulation Manufacturing to lead production for protein formulations, drive scale-up, and manage tech transfer. You will oversee GLP batch manufacture, stability studies, and cross-functional collaboration with R&D, analytical, and CMOs to ensure compliant, robust processes.

Requirements include an MS in a biochemical/engineering field, 8+ years in pharma manufacturing, and 3+ years of supervision, with strong leadership and project-management skills.

Qualifications

• Requires proven track record leading manufacturing operations and teams for protein formulations.
• Leads production schedules and development timelines per product quality standards.
• Oversees stability studies and root-cause analysis for process issues.
• Extensive experience in cGMP environments, including aseptic fill/finish.
• Drives continuous improvement across processes, equipment, and workflows.

Responsibilities

• Direct and plan all production for formulation development batches.
• Lead pilot-scale work and manufacture GLP batches for partners as needed.
• Compile data and use metrics to identify trends and drive quality improvements.
• Oversee technology transfer and process validation to ensure comparability.
• Review SOWs to support tech transfer and scale-up activities.
• Identify risks and implement corrective actions to optimize operations.
• Lead cross-functional teams and maintain thorough documentation.

Skills

Leadership

Manufacturing operations

Project management

cGMP

Root-cause analysis

Process scale-up

Documentation

Cross-functional collaboration

Aseptic fill/finish

Risk mitigation

Education

MS in biochemistry/chemical engineering

BS with 10+ years experience

3+ years supervisory experience

Tools

Project management software

Document management systems

Job description

ClinLab Solutions Group seeks a Director of Formulation Manufacturing to lead production for protein formulations, drive scale-up, and manage tech transfer. You will oversee GLP batch manufacture, stability studies, and cross-functional collaboration with R&D, analytical, and CMOs to ensure compliant, robust processes.

Requirements include an MS in a biochemical/engineering field, 8+ years in pharma manufacturing, and 3+ years of supervision, with strong leadership and project-management skills.