Product Characterisation Specialist

Biopharmaceutical company who are determined to enable people to live healthier lives by delivering pioneering medicines in neuroscience, oncology and rare diseases. This position is on a permanent basis and will be based at the Wrexham site.

Job Responsibilities:

• Drive the development and implementation of state-of-the-art analytical methods and scientific approaches, incorporating protein characterisation by mass spectrometry, HPLC methods (RP-HPLC, SEC, ion exchange) and capillary electrophoresis (cIEF and CE-SDS) to elucidate the structure, modifications and degradation pathways of biologic products developed by the organisation.
• Support the development and implementation of bioprocess analytical techniques including targeted mass spectrometry to characterise biologic products and bioprocesses to effectively support bioprocess and formulation development, optimisation and validation as part of a control strategy for product quality.
• Implement DOE approaches to method development and support method transfer and qualification/validation where required.
• Support multiple analytical programs with efficient co-ordination of workload to deliver key Biologics development and lifecycle management projects on time.
• Effectively plan, schedule and perform analytical work, including protocol and report preparation, data review, trending and tracking, to required quality standards.
• Build the science by increasing product and process understanding in accordance with the relevant regulatory guidelines.
• Maintain high level of expertise through review of current scientific literature, submissions to scientific journals, and attendance and participation at conferences.
• Support improvements to Analytical Development systems and processes and seek opportunities to boost productivity and efficiency.

Key Skills:

• Ability to work in diverse and multi-cultural technical teams.
• Desire to learn new product characterisation techniques (e.g. liquid chromatography mass spectrometry methods).
• Ability to present and articulate complex technical topics to technical and non-technical stakeholders.

Requirements:

• BSc and PhD equivalent experience with relevant analytical protein characterisation training/expertise.
• PhD level (or equivalent), with relevant Biopharmaceutical R&D industry experience in analytical approaches for Biologic product and/or bioprocess characterisation.
• Good understanding and experience of analytical characterisation of products and/or bioprocesses.
• Knowledge and technical capabilities in assay development, implementation, qualification and testing for biologic products.
• Knowledge of regulatory submissions, briefing documents and CMC documentation, as required, to ensure the successful approval of new products.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.