Hybrid Tech Transfer Lead, Biologics Drug Substance

Orion Group; Dublin; Hybrid; EUR 110.000 - 150.000; Vollzeit

Zusammenfassung

Orion Group Life Sciences is seeking a Tech Transfer Lead for Drug Substance in Dublin on a 12‑month hybrid contract.

You will lead end‑to‑end technology transfer from development to GMP manufacturing and coordinate cross‑functional teams across Process Development, Manufacturing, Quality, Analytical, Supply Chain, MSAT, Regulatory, and CDMOs to ensure timely, compliant transfers for clinical and commercial production of biologics.

Qualifikationen

• Bachelor’s degree in Biology, Biochemistry, Chemical Engineering, Biotechnology, or related field.
• 5–8+ years in biologics process development, MSAT, manufacturing, or tech transfer.
• Strong knowledge of drug substance manufacturing for biologics (upstream/downstream).
• Experience with cGMP, process validation, and quality systems.
• Proven ability to lead cross-functional projects and teams.
• Excellent communication and stakeholder management skills.
• Willingness to travel as needed for site-to-site transfers.

Aufgaben

• Lead end-to-end technology transfer activities for drug substance biologics processes (cell culture, upstream, downstream, analytical).
• Develop and execute transfer strategies, plans, timelines, risk assessments, readiness assessments.
• Partner with development teams to transfer process knowledge and critical parameters.
• Coordinate creation, review, and approval of transfer docs (descriptions, plans, BOMs, protocols).
• Lead cross-functional transfer teams and governance meetings for scope and milestones.
• Support process scale-up, characterization, comparability, and validation activities.
• Ensure analytical methods, sampling plans, and materials align with transfers.
• Identify risks and drive mitigation plans to resolution.
• Collaborate with Quality and Regulatory for cGMP compliance.

Kenntnisse

Cross-functional collaboration

Communication

Problem-solving

Stakeholder management

Travel readiness

Ausbildung

Bachelor’s degree in Biology, Biochemistry, Chemical Engineering, Biotechnology, or related field

Jobbeschreibung

Orion Group Life Sciences is seeking a Tech Transfer Lead for Drug Substance in Dublin on a 12‑month hybrid contract.

You will lead end‑to‑end technology transfer from development to GMP manufacturing and coordinate cross‑functional teams across Process Development, Manufacturing, Quality, Analytical, Supply Chain, MSAT, Regulatory, and CDMOs to ensure timely, compliant transfers for clinical and commercial production of biologics.