USP Manufacturing Specialist (Level III)

A speciality biopharmaceutical company is currently recruiting a USP Manufacturing 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:

• To work in accordance with cGMP and EHS practices, conducting all activities in a compliant and safe manner. Willing to take on additional activities with only moderate supervision.
• The individual will need to perform cGMP activities in Grade CNC, D and C areas.
• Culture mammalian cells aseptically from cell revival stage in shake flask until end of production process in Single use bioreactors in accordance with the relevant protocols.
• Prepare media and buffers to set specifications in accordance with written protocols.
• Proactively ensure the USP suite and equipment is maintained in a state of Inspection readiness at all times.
• Be a SME author/reviewer and/or approver for written procedures, SOPs, BMRs and other cGMP documentations in span of expertise.
• Assist in execution of technical and validation protocols.
• Contribute to investigations as required, to help identify root cause and appropriate corrective actions.
• Supervise and ensure laboratory work is carried out according to cGMP.
• Coach and mentor new starters to contribute to achieving a multi-skilled and engaged USP team.
• Contribute as required to successful commercial Pre-Approval Inspections (PAIs), regular Audits and any other interactions with regulatory agencies.
• Actively involved in tasks that involve other departments in the company, in addition to other tasks assigned to him/her.
• Continually identify process improvement to help create and maintain a lean, flexible and agile manufacturing facility.
• Demonstrate operational excellence within functional area of responsibilities.
• Adhere to the company etiquette in all matters of behaviour and manners.

Skills and Requirements:

• Degree in related discipline or sufficient relevant experience.
• Knowledge/experience of mammalian cell culture for production of monoclonal antibodies and recombinant protein therapeutic products.
• Hands-on experience operating upstream processing equipment.
• Knowledge/experience of cell culture principles, techniques, scale up, technology transfer and process validation activities.
• Knowledge/experience of supporting Pre-Approval Inspections (PAI) and working with international regulatory agencies including the FDA and EMA.
• Knowledge of cGMP compliance and associated documentation.
• Minimum of 3 years in biopharmaceuticals or technical field, desired.
• Proven experience of collaborative team-working, leading when appropriate.
• 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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