Posted: 18 June
The role
Step Into a Technical Leadership Role Driving Biotech Innovation
Process Engineer III - Tech Transfer Lead (Drug Substance Biotech)
Imagine being the person who bridges scientific innovation and commercial manufacturing, ensuring that complex biologic processes are successfully transferred into GMP production environments. Every project you lead contributes to bringing life‑changing therapies from development into reliable manufacturing, helping ensure patients receive the treatments they depend on.
This opportunity sits within a highly regulated biotechnology environment where technical expertise, cross‑functional collaboration, and project leadership are essential to successful technology transfer and process implementation.
What you'll achieve (and why it matters):
Lead end‑to‑end technology transfer activities for biologics drug substance manufacturing processes, including upstream and downstream operations
Develop and execute transfer strategies, project plans, risk assessments, and readiness activities to support successful process implementation
Partner with process development teams to transfer process knowledge, critical process parameters, and control strategies into manufacturing operations
Coordinate the creation, review, and approval of technical transfer documentation, protocols, reports, and process summaries
Lead cross‑functional project teams, facilitating alignment across Manufacturing, Quality, Analytical, Supply Chain, Regulatory, and Technical Operations
Support process scale‑up, characterization, validation, and comparability activities throughout the transfer lifecycle
Ensure manufacturing sites have the equipment, materials, analytical methods, and systems required for successful execution
Identify technical and operational risks and drive mitigation plans to resolution
Support investigations, change controls, deviations, and CAPA activities associated with technology transfer programs
Provide technical oversight during engineering runs, validation campaigns, and process verification activities
Drive continuous improvement initiatives using Lean Six Sigma and change management methodologies to improve process robustness and operational performance
Your edge (desired, not required):
Degree in Chemical Engineering, Biotechnology, Biochemistry, Biology, or a related scientific discipline
5+ years of experience in biotechnology manufacturing, process engineering, MSAT, process development, or technology transfer
Strong understanding of biologics manufacturing processes, including upstream and downstream operations
Experience working within GMP‑regulated pharmaceutical or biotechnology environments
Proven ability to lead cross‑functional technical projects and manage multiple stakeholders
Strong analytical, problem‑solving, and communication skills
Experience supporting process validation, scale‑up, or commercial manufacturing activities advantageous
Exposure to external manufacturing partners, CMOs, or CDMOs would be beneficial
Lean Six Sigma or project management experience highly regarded
Why this role matters:
This is an opportunity to play a key role in transferring innovative biologic manufacturing processes into commercial production. You will work at the intersection of science, engineering, and operations while helping to ensure manufacturing excellence, regulatory compliance, and successful product delivery within a global biotechnology network.
The next step for you:
If this opportunity is of interest, please send your CV or reach out to discuss further.
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