Biologics Tech Transfer Lead - Drug Substance

PSC Biotech Corporation; Dublin; Hybrid; EUR 90,000 - 140,000; Full time

Benefits offered by this job

Hybrid working

Job summary

PSC Biotech Corporation is seeking a Tech Transfer Lead for Drug Substance Biotech in Ireland. The role focuses on leading transfers of biologics manufacturing processes from development to GMP production, coordinating internal and external partners across QA, Regulatory, Manufacturing, and Supply Chain.

The position demands a strong cross-functional leader capable of delivering compliant, timely transfers.

Qualifications

• Excellent communication, organization, problem-solving and stakeholder management skills.
• Bachelor’s degree in Biology, Biochemistry, Chemical Engineering, Biotechnology or related field.
• Master’s degree or PhD in a relevant discipline preferred.

Responsibilities

• Lead end-to-end technology transfer activities for drug substance biologics processes, including cell culture, upstream and downstream operations and analytical methods.
• Develop and execute transfer strategies, project plans, timelines, risk assessments and readiness assessments.
• Coordinate creation, review and approval of transfer documentation including process descriptions, sample plans, bill of materials, protocols, reports and technical summaries.
• Lead cross-functional transfer teams and governance meetings to ensure alignment on scope, milestones and risks.
• Support process scale-up, characterization, comparability and process validation activities as required.
• Ensure analytical methods, sampling plans, materials, equipment and facility requirements align to support successful transfer.
• Identify risks and drive mitigation plans to resolution.

Skills

Communication

Organization

Problem solving

Stakeholder management

Education

Bachelor’s degree in Biology/Biochemistry/Chemical Engineering/Biotechnology

Master’s or PhD preferred

Job description

PSC Biotech Corporation is seeking a Tech Transfer Lead for Drug Substance Biotech in Ireland. The role focuses on leading transfers of biologics manufacturing processes from development to GMP production, coordinating internal and external partners across QA, Regulatory, Manufacturing, and Supply Chain.

The position demands a strong cross-functional leader capable of delivering compliant, timely transfers.