DSP Development Scientist - Process Characterisation

A speciality biopharmaceutical company is currently recruiting a DSP Development Scientist - Process Characterisation to join their office in Reykjavik. This organisation is renowned for its work on high-quality biosimilar products, ranging across the value chain from cell line development to commercial manufacturing. This is an exciting opportunity to work with a dynamic and upcoming company and bolster a career in the biosimilar space.

Job Responsibilities:

• Utilise a QbD (quality by design) and DoE (design of experiment) approach to develop, scale up, and troubleshoot downstream processing of monoclonal antibody products.
• Ensure the complete and accurate documentation of lab activities and write appropriate technical reports for successful regulatory submissions.
• Provide technical and scientific guidance to team members in order to contribute to a multi-skilled and engaged DSP Development team.
• Maintain a leading-edge knowledge and understanding of new technologies and innovations in the field of MAb cell culture and production and proactively share knowledge for the benefit of others.
• Ensure the DSP development labs and equipment are maintained under optimal working conditions.
• Contribute to investigations (e.g. deviations) as required, to help identify root causes and assign appropriate corrective actions.
• Support tech transfer with manufacturing organizations (internal and external), scale up, troubleshooting, process changes, and regulatory submissions.
• Support manufacturing campaigns as subject matter expert (SME).
• As a Subject Matter Expert, contribute to successful commercial Pre-Approval Inspections (PAIs), regular Audits, and any other interaction with regulatory agencies as required.

Skills and Requirements:

• Preferably qualified to PhD level in a relevant scientific discipline, or relevant industry experience.

• Experience in the downstream processing of proteins.
• Scientific knowledge and understanding of downstream purification, monoclonal antibodies, and recombinant protein therapeutic products.
• Experience with Design of Experiment (DOE) software preferable.
• Knowledge of Chromatography principles and techniques.
• Proven experience of collaborative team-working.
• Knowledge/experience of Running and reporting complex experiments.
• Ability to report technical information in a written and verbal format.
• Demonstrable project management skills.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Owen Bach at +44 203 826 1330 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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