USP MSAT Specialist (Level II)

A speciality biopharmaceutical company is currently recruiting a USP 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:

• Contributing 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.
• Introducing and supporting the qualification of new processes into cGMP manufacturing, whilst managing technical risks associated with process transfer, leading cross functional teams to ensure relevant transfer, and communicating critical process and technical information such that successful outcomes are achieved.
• Investigating, identifying root causes, and identifying CAPA for manufacturing deviations.
• Providing independent, on-plant technical support, process monitoring, and complex data analysis, using experience to anticipate issues before they become critical.
• Representing MSAT within multiple complex external/internal project teams and pro-actively communicating, effectively negotiating, collaborating via both face-to-face meetings and telecoms, driving problem resolution and offering successful technical outcomes.
• Leading process optimization/improvement activities; leading cross functional teams to successfully implement according business needs.
• Using technical influence and knowledge in project teams to the ensure delivery of project timelines according to business needs.
• Proactively anticipating, evaluating, and resolving technical challenges within area of expertise
• Managing and resolving gaps in unit operations through batch reviews and applied continual process learning/knowledge capture.
• Following external biopharmaceutical manufacturing technology advancements; understanding and introducing new technologies and how they may be applicable to process innovation, cost, or yield improvement.
• Coaching and mentoring new starters to contribute to achieving a multi-skilled and engaged USP team.
• Adhering to the company etiquette in all matters of behaviour and manners.
• Working in accordance with cGMP and EHS practices, conducting all activities in a compliant and safe manner. Willing to take on additional activities with little or no supervision.

Skills and Requirements:

• Degree in Biological science or biochemical engineering disciplines or equivalent.
• Demonstrable ability with significant experience in industry or a relevant academic environment
• 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.
• Be a recognized expert in field USP drug substance operations from working in a cGMP environment.
• A minimum of 2 years technical transfer expertise gained from a drug substance manufacturing environment.
• Have demonstrable experience working in cross functional project management and technical transfer activities with ability to multi task, prioritize and be an effective decision maker.
• Have a deep understanding of manufacturing process as a whole e.g. Supply chain, analytical, QA.
• 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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