Senior MS&T Specialist

Senior MS&T Specialist - Analytical - Dublin - 12-Month Contract 

An exciting opportunity has arisen for an experienced MS&T Senior Specialist to support MS&T sciences as the subject matter expert in analytical methods and process analytical technologies.

The role offers convenient access to Dublin Airport.

You will be working with a leading biologics-based client, specialising in immuno-oncology and biologics drug substance manufacturing, contributing to one of the best-selling drugs worldwide.

The role:

• Biologics analytics and characterisation SME, providing technical input to teams, and coaching to associate staff. Provide technical leadership for:
  • Experimental design, execution, data analysis and interpretation.  
  • Development,transfer and qualification of assays.
• Lead and support various  MS&T initiatives 
• Technical point of contact for Process Analytical Technologies (PAT)
• Technical lead for characterisation testing, ensuring testing conducted either internally or externally
• Serving as a key member during internal audits and external inspections/audits
• Author and review of documents including (URSs), Risk Assessments, Protocols, Reports, Standard Operating Procedures (SOPs), work instructions

Skills & Experience required:

We are looking for a minimum of 6 years’ (for MSc), 8 years’ (for BSc) directly related experience in academia, pharmaceutical or biotechnology company – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.

Experience with assay development and qualification of biologics assays (HPLC-based, ELISA, etc).  Familiarity with potency assays, including cell-based assays.

• Experience with analytical testing in support of upstream cell culture and downstream purification of biological molecules.   Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
•  Significant amount of Analytical Chromatography experience ideally with some Mass Spectrometry experience
• Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing
• Working knowledge of statistical methods for DOE design and data analysis 
• Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for biologics processe.

If this role is of interest to you, please apply now! 

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