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̽»¨ºÏ¼¯ is seeking a Senior Upstream Biotechnologist to join a specialist team. This role will focus on aseptic mammalian cell culture and upstream processing operations. The successful candidate is someone who can work independently and is ready to take on additional responsibilities. This position is crucial for maintaining compliance with cGMP and EHS standards.

Responsibilities:

• Conduct cGMP operations in Grade CNC, D, and C areas.
• Aseptically culture mammalian cells from revival to production using single-use bioreactors.
• Prepare media and buffers as per specified procedures.
• Maintain the USP suite and equipment for inspection readiness.
• Act as a subject matter expert for SOPs, BMRs, and cGMP documentation.
• Support technical and validation protocol execution.
• Lead investigations into deviations and implement corrective actions.
• Contribute to technology transfer for manufacturing scale processes.
• Ensure laboratory work complies with cGMP standards.
• Mentor and train new team members.
• Participate in commercial Pre-Approval Inspections and audits.
• Collaborate with other departments and complete additional tasks.
• Identify and implement process improvements for a lean manufacturing environment.
• Exhibit operational excellence in all responsibilities.

Key Skills and Requirements:

• Degree in a related discipline or relevant experience.
• Knowledge of mammalian cell culture for monoclonal antibodies and recombinant proteins.
• Experience with upstream processing equipment.
• Understanding of cell culture principles, scale-up, technology transfer, and process validation.
• Familiarity with Pre-Approval Inspections and international regulatory agencies like FDA and EMA.
• Strong 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.

̽»¨ºÏ¼¯ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ̽»¨ºÏ¼¯ is acting as an Employment Agency in relation to this vacancy.