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���߲�ӰԺ is collaborating with a biotech company to recruit a Senior DSP for their team in Iceland. This position centers on downstream processing within a cGMP environment, with a focus on protein purification and production. The ideal candidate will be proactive, capable of working independently, and dedicated to upholding high standards of safety and compliance.

Responsibilities:

• Conduct activities in accordance with cGMP and EHS practices.
• Perform cGMP activities in Grade CNC, D, and C areas.
• Train in purification activities from protein A chromatography to freeze operations.
• Provide subject matter expertise for DSP processing steps.
• Maintain DSP suite and equipment in a state of inspection readiness.
• Author, review, and approve written procedures, standard operating procedures, BMRs, and other cGMP documentation.
• Assist in the execution of technical and authentication protocols.
• Lead and coordinate investigations for deviations, identifying root causes and corrective actions.
• Ensure QMS records are managed within defined KPIs.
• Contribute to the technology transfer of processes to manufacturing scale.
• Supervise and ensure manufacturing activities comply with cGMP.
• Coach and mentor new team members.
• Support commercial Pre-Approval Inspections (PAIs) and audits.
• Collaborate with other departments and contribute to process improvements.

Key Skills and Requirements:

• Degree in a related discipline or equivalent relevant experience.
• Knowledge and experience in downstream purification processes for monoclonal antibodies and recombinant protein therapeutic products.
• Hands-on experience with downstream processing equipment.
• Experience in purification techniques, scale-up, technology transfer, and process authentication.
• Proven experience in coaching and mentoring.
• Experience supporting Pre-Approval Inspections (PAI) and working with international regulatory agencies such as the FDA and EMA.
• Expertise in cGMP compliance and associated documentation.

If you are having difficulty in applying or if you have any questions, please contact Ruhee Saleh at r.saleh@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.

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