DSP MSAT Specialist (Level II)

A speciality biopharmaceutical company is currently recruiting a DSP MSAT 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:

• Contribute towards Scale-up strategy prior to tech transfer of manufacturing processes to GMP Manufacturing across clinical and commercial, to both internal and external manufacturing sites if needed.
• Introduce and support the qualification of new processes into cGMP manufacturing, whilst managing technical risks associated with process transfer.
• Lead cross functional teams to ensure relevant transfer and communication of critical process and technical information such that successful outcomes are achieved as agreed.
• Investigate, identify root cause, and identify CAPA for manufacturing deviations.
• Provide for independent on plant technical support, process monitoring, and complex data analysis using experience to anticipate issues before they become critical.
• Represent MSAT within multiple complex external/internal project teams and pro-actively communicate, effectively negotiate, and collaborate via both face to face meeting and telecoms to drive problem resolution and offer successful technical outcomes.
• Lead process optimization/improvement activities, leading cross functional teams to successfully implement according business needs.
• Use technical influence and knowledge in project teams to ensure delivery of project timelines according to business needs.
• Proactively anticipate, evaluate, and resolve technical challenges within area of expertise.
• Resolve gaps in unit operations through batch reviews and applied continual process learning/knowledge capture.
• Follow external biopharmaceutical manufacturing technology advancements; understand and introduce new technologies and how they may be applicable to process innovation, cost, or yield improvement.
• Coach and mentor new starters to contribute to achieving a multi-skilled and engaged DSP team.
• Adhere to the company etiquette in all matters of behaviour and manners.

Skills and Requirements:

• Degree in Biological science or biochemical engineering disciplines or equivalent.
• Experience of cell culture principles, techniques, scale up, technology transfer, and process validation activities.
• Strong knowledge in laboratory development and/or a manufacturing operations background.
• Expertise in field DSP drug substance operations from working in a cGMP environment.
• A minimum of 2 years technical transfer expertise gained from a drug substance manufacturing environment.
• A deep understanding of manufacturing process as a whole e.g. Supply chain, analytical, or QA.
• Proven experience of coaching and mentoring others.
• 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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