Tech Transfer Lead - Pharmaceutical Manufacturing

CSL; Holly Springs (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

CSL Vifor is seeking a seasoned Technology Transfer Specialist to lead cross-site transfer programs, troubleshoot process and manufacturing challenges, and author critical validation and compliance documentation. You will coordinate with Manufacturing, MS&T, Quality, Regulatory, and external partners to ensure successful commercialization globally.

A strong background in GMP-driven biotech/pharma processes and regulatory familiarity is required.

Qualifications

• Bachelor's degree in a relevant branch of Biological Science or Engineering.
• 3-5 years' hands-on experience in process development activities.
• Knowledge of FDA/EMEA/TGA GMP production regulations.
• Pharmaceutical/biotech experience preferred.
• Local legal/educational requirements may alter qualifications.

Responsibilities

• Lead technology transfer projects across internal sites and external partners, ensuring deliverables and timelines.
• Provide technical manufacturing support for process, equipment, and operations challenges, including investigations and risk assessments.
• Author and maintain transfer plans, batch records, protocols, specifications, and related compliance documents.
• Coordinate cross-functional activities across Manufacturing, MS&T, Quality, Engineering, Regulatory, Supply Chain, and CMOs/CDMOs to reach milestones.
• Maintain process/equipment/automation knowledge to support transfer, yield, reliability, and safety improvements.
• Support regulatory and quality activities, including submissions, deviations, CAPAs, OOS, OOE, and complaint investigations.
• Manage readiness activities: enrollments, BOM updates, system changes, and demonstrations/validations for global commercialization.

Skills

Project leadership

Cross-functional collaboration

Technical troubleshooting

Education

Bachelor's degree in Biological Science or Engineering

Job description

CSL Vifor is seeking a seasoned Technology Transfer Specialist to lead cross-site transfer programs, troubleshoot process and manufacturing challenges, and author critical validation and compliance documentation. You will coordinate with Manufacturing, MS&T, Quality, Regulatory, and external partners to ensure successful commercialization globally.

A strong background in GMP-driven biotech/pharma processes and regulatory familiarity is required.