Senior Fill-Finish Biotechnologist

Proclinical is collaborating with a biotech company currently seeking a Senior Fill-Finish Biotechnologist to join the team in Iceland. In this role, you will collaborate with the DPM Team Leaders and DP Manufacturing team to ensure the manufacturing schedule is met safely and in compliance with cGMP and regulatory standards. This position focuses on training, maintaining inspection readiness, and continuous professional development.

Responsibilities:

• Assist in training staff members and documenting training in a compliant manner.
• Act as an SME author/reviewer/approver for written procedures and SOPs.
• Ensure the DP manufacturing suite and equipment are maintained in a state of inspection readiness through proactive interaction with other departments.
• Stay updated on new regulatory requirements and technical developments.
• Share knowledge proactively for the benefit of the team.
• Contribute to the technical transfer of new processes/products into manufacturing.
• Identify process improvement and waste elimination opportunities.
• Train, coach, and mentor less experienced staff members.
• Act as an SME author of Deviations and CAPAs related to DPM processes.
• Deputize for the DPM Team Leader as required.
• Perform cGMP activities within A, B, and C environments, focusing on cleanroom behaviors.
• Conduct pre- and post-production activities, including line clearances.
• Manage material transfer and general upkeep in CNC and Grade C areas.
• Complete gowning qualification, cleaning, setup, and testing in Grade A/B areas.
• Monitor the EMS in coordination with the line manager.
• Complete all required batch-related documentation, including forms and logbooks.

Key Skills and Requirements:

• Education in a technical discipline such as biotechnology, engineering, or biochemistry is advantageous.
• Experience in (bio)pharmaceuticals, with a focus on fill-finish and aseptic manufacturing.
• Strong leadership and organizational skills.
• Excellent written and verbal communication skills.
• Proficiency in using a PC and common Microsoft packages such as Word, Visio, and Excel.

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.

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.