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Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

Senoior Specialist - MS&T


Reference:SMC21742 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Scientist

We’re currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Swords. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

  • Serving as a biologics analytics and characterization 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 organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
  • Technical point of contact for Process Analytical Technologies (PAT)
  • Authoring and reviewing of documents including User Requirements Specifications (URSs), Risk Assessments, Protocols, Reports, Standard Operating Procedures (SOPs), work instructions
  • Technical lead for characterization testing, ensuring testing conducted either internally or externally
  • Serving as a key member during internal audits and external inspections/audits
  • Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus
Education & Experience
  • 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 interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.