DSP Manufacturing Specialist (Level II)

A speciality biopharmaceutical company is currently recruiting a DSP Manufacturing Specialist (Level II) 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:

• Work in accordance with cGMP and EHS practices, all activities in a compliant and safe manner. Willing to take on additional activities with only moderate supervision.
• Perform cGMP activities in Grade CNC, D and C areas.
• Aseptically purify monoclonal antibodies and protein products by operating column chromatography and filtration.
• Prepare buffers to set specifications in accordance with approved procedures.
• Proactively ensure the DSP suite and equipment is maintained in a state of inspection readiness at all times.
• Act as an SME author/reviewer and/or approver for written procedures, SOPs, BMRs, and other cGMP documentations.
• Assist in execution of technical and validation protocols.
• Contribute to investigations as to help identify root cause and appropriate corrective.
• Supervise and ensure laboratory work is carried out according to cGMP.
• Coach and mentor new starters to contribute to achieving a multi-skilled engaged DSP.
• Contribute as required to successful commercial Pre-Approval inspections (PAls), regular Audits, and any other interactions with regulatory agencies.
• 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 professional experience.

• Knowledge/experience of protein purification for production of monoclonal antibodies and recombinant protein therapeutic products.
• Hands-on experience operating downstream processing equipment.
• Knowledge/experience of protein purification 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.
• At least 3 years of experience in biopharmaceuticals or technical field is desired.
• Proven experience of collaborative team-working and leading where 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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