Senior Downstream Biotechnologist - Nordics

Proclinical is seeking a Senior Downstream Biotechnologist to join a dedicated team. This role will focus on ensuring compliance with cGMP and EHS standards, conducting purification processes, and maintaining equipment readiness. This position requires a proactive approach to responsibilities and a commitment to safety and quality. This position requires relocation to Iceland.

Responsibilities:

• Ensure all tasks are performed safely and in compliance with cGMP and EHS standards.
• Conduct cGMP operations in designated areas.
• Receive and apply training on purification processes, including protein A chromatography.
• Maintain the DSP suite and equipment for inspection readiness.
• Act as a subject matter expert for procedures, SOPs, and cGMP documentation.
• Support technical and validation protocol execution.
• Assist in investigations to identify root causes and recommend corrective actions.
• Oversee manufacturing activities to ensure cGMP compliance.
• Provide coaching and mentorship to new team members.
• Support successful outcomes during inspections, audits, and regulatory interactions.

Key Skills and Requirements:

• Degree in a related discipline or relevant experience.
• Experience in downstream purification for monoclonal antibodies and recombinant proteins.
• Hands-on experience with downstream processing equipment.
• Knowledge of cell purification techniques, scale-up, technology transfer, and process validation.
• Proven collaborative team-working skills and leadership when appropriate.
• Experience supporting Pre-Approval Inspections and working with regulatory agencies like FDA and EMA.
• Knowledge of cGMP compliance and documentation.

If you are having difficulty in applying or if you have any questions, please contact Dominic Williams at d.williams@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.