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Senior Specialist MS&T

  1. Dublin
Dublin
  1. Contract
Competitive
  1. CAPEX Projects
34721

This vacancy has now expired

Senior Specialist MS&T - Pharmaceuticals - 12-Month Contract+ 

Do you want to be involved with exciting Pharmaceutical projects?

When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a Senior Specialist MS&T.

This a fantastic opportunity to be involved with the critical investment projects both on-site and remotely.


Responsibilities: 
  • Serving as a biologics analytics and characterisation subject matter expert, 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 manufacturing science and technology organisational initiatives as needed (examples include safety, financial forecasting, work standardisation, etc).
  • 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
  • Authoring and reviewing of documents including User Requirements Specifications (URSs), Risk Assessments, Protocols, Reports, Standard Operating Procedures (SOPs), work instructions
  • Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus

Requirements: 
  • Demonstrated leadership and change management skills with a continuous improvement focus.
  • A self-starter and results-focused, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams. The successful candidate will also have demonstrated the ability to deliver what is needed on-time, holding self and team accountable for commitments, decisions, actions and behaviours.
  • S/he will also have excellent oral and written communication skills, with the ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
  • With a Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry, the successful candidate will also ideally have a proven track record in delivering excellence.
  • This role requires an experienced individual with 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.

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

 #LI-JS5
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