Tech Transfer Lead

Description

Provide technical and process development support for new product introductions (NPI) and lifecycle management (LCM) changes. This role will contribute to biologics drug product manufacturing as part of the global Process Development organization and will play a key role in supporting the transition to a new facility housing single-use end-to-end processes and syringe filling lines.

• Collate and report on shipping and filter validation activities.
• Manage product transfer projects from initiation to full transfer, including line characterization, engineering studies, process performance qualification (PPQ), and regulatory approval.
• Participate in cross-functional process validation teams to meet project milestones and organizational goals.
• Provide process development expertise for commercial drug product processing, including sterile processing, process characterization, tech transfer, and validation.
• Contribute to site validation programs, guidance documents, deviation and exception resolution, root cause analysis, and product quality assessments.
• Lead or support NPIs from concept through PPQ, ensuring successful product transfer and regulatory filings.
• Troubleshoot challenges with drug substance freezing/thawing, formulation, syringe filling, inspection, and transportation during NPI or post-NPI phases.
• Develop characterization studies, engineering runs, electronic batch records, validation plans, and PPQs for syringe filling operations.
• Pre-approve and post-approve process validation protocols and assessments from a quality system perspective.
• Participation in 24/7 support once or twice per quarter (1–2 weeks) as required.
• Serve as the primary site contact for transfer projects with drug product teams and Global Operations Teams.
• Ensure all process validation activities comply with company policies, safety standards, and training requirements.
• Support commercial drug product operations with evaluation of Change Control, Non-Conformance (NC), CAPA, and technology transfer activities.

Requirements

• Bachelor’s degree in science, engineering, or equivalent discipline with 5 years’ experience in commercial manufacturing or NPI roles; OR
• Master’s or Doctorate in Science or Engineering.
• Knowledge of cGMP and international regulatory requirements.
• Experience in commercial protein drug product processing, including sterile processing, process characterization, tech transfer, or validation.
• Knowledge of Quality Systems, Drug Product Manufacturing, and Validation.
• Associate degree with 7 years’ directly related experience.
• Moderate international travel may be required.
• Master’s degree with 3 years’ directly related experience; OR
• Proven ability to lead cross-functional teams to deliver complex projects.
• Excellent communication and stakeholder management skills.
• Strong understanding of protein freeze-thaw, filtration, mixing, filling (PPQ/batch homogeneity), and protein stability principles.
• Strong problem-solving, oral, and written communication skills.
• Project management experience, including coordination of multiple projects and resource evaluation.

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance