Senior Analytical Specialist

2 days ago

Cork, Cork, Ireland beBeeAnalytical Full time €55,000 - €80,000
Job Overview

This role is focused on analytical operations in support of clinical and commercial programs, formulation development, quality control testing to support GMP operations for Solid Oral Dosage & Biologics Portfolio of Products.

The successful candidate will reside in the overall QC function and be responsible for QC analytical activities associated with New Product Introduction of Biologic products, solid oral dose products, analytical method development & validation, transfer activities and Process & Cleaning Validation analysis as appropriate.

Key responsibilities include analytical support of Method Validation/Transfers for Biological & Solid Oral Dose Products as appropriate with specific emphasis on Biologic/Large molecule activity, execution of process and cleaning validation studies in support of New Product Introductions, provision of technical support to Operations for investigations and optimisation projects, and delivery of new technologies and continuous improvement initiatives to meet business requirements.

  • Analytical support of Method Validation/Transfers for Biological & Solid Oral Dose Products as appropriate with specific emphasis on Biologic/Large molecule activity.
  • Execution of process and cleaning validation studies in support of New Product Introductions.
  • Provision of technical support to Operations for investigations and optimisation projects.
  • Deliver new technologies and continuous improvement initiatives to meet business requirements.

Required skills and qualifications include relevant experience in test methods for biologic and biopharmaceutical products, strong knowledge and understanding of cGMP, quality control (QC), and regulatory requirements for GMP laboratories in pharmaceutical industry, advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs), hands-on experience with equipment qualification and analytical techniques such as CE-SDS, CEX-HPLC, SE-HPLC, cIEF, Peptide mapping, UPLC/HPLC is essential, and knowledge of software such as Empower, SOLO VPE and LIMS.

  • Relevant experience in test methods for biologic and biopharmaceutical products.
  • Strong knowledge and understanding of cGMP, quality control (QC), and regulatory requirements for GMP laboratories in pharmaceutical industry.
  • Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs).
  • Hands-on experience with equipment qualification and analytical techniques such as CE-SDS, CEX-HPLC, SE-HPLC, cIEF, Peptide mapping, UPLC/HPLC is essential.
  • Knowledge of software such as Empower, SOLO VPE and LIMS.
Typical Qualifications
  • Relevant experience with BSc degree in Biopharmaceutical Science, Chemistry or equivalent.
  • Bio-analytical testing experience is essential per the techniques already listed.

 

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