Drug Product MSAT Specialist (Level III)

A speciality biopharmaceutical company is currently seeking a Drug Product MSAT Specialist (Level III) 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:

• Working cross-functionally to lead/support manufacturing related process improvements, process validation, process change control, deviation investigation, and technical troubleshooting to help maintain a lean, flexible, and agile manufacturing facility.
• Working cross-functionally to plan, implement, and review CAPAs and change controls related to DP Manufacturing.
• Identifying process improvement and waste elimination opportunities to help create and maintain a lean, flexible and agile manufacturing facility.
• Leading selection and managing vendors of new equipment, services, and materials to support DP Manufacturing activities.
• Adhering to budget and resource management for all assigned projects according to guidance given by management.
• Formulating and informing strategies for the successful and smooth technical transfer of new processes and products into manufacturing (including development of theoretical and practical small-scale models as required).
• Informing and managing strategies for process characterisation/ validation.
• Training, coaching, and mentoring less experienced members of staff.
• Acting as a Subject Matter Expert and key team member; contributing to successful commercial Pre-Approval Inspections (PAIs), regular Audits, and any other interaction with regulatory agencies as required.
• Highlighting critical process parameters and critical quality attributes defined through DP development studies and tracking and trending data related to in order to ensure process consistency and comparability.
• Implementing and ensuring process performance measurements through multivariate modelling and statistical measurements of CP, CPK, PP, and PPK.
• Implementing and ensuring key performance indicators for DP Manufacturing, adhering to the concepts of lean manufacturing.
• Generating scientific documents to support the generation of international registration documents, support registration, and contracting activities.
• Supporting all external manufacturing activities.

Skills and Requirements:

• Industry experience in pharmaceutical development and/or manufacturing of finished dosage forms for biopharmaceuticals.
• Knowledge of GMP, Process Characterization and Validation.
• 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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