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À±½·ÊÓƵ 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.

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.

À±½·ÊÓƵ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. À±½·ÊÓƵ is acting as an Employment Agency in relation to this vacancy.