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Senior Associate Scientist

Job Title: Senior Associate Scientist
Location: Cork
Industry:
REF: 93138
Job Published: 8 months ago

Job Description

Contact: Caroline Kingston
Email: caroline@hero.ie
Telephone: 086 8395531

Senior Associate Scientist
Our client, a pharmaceutical company in Cork are currently looking to recruit a Senior Associate Scientist for their site.

Main duties and responsibilities:
  • Provision of bioassay technical support for binding assays (e.g. ELISA and TR-FRET) and cell based bioassays (eg ADCC assays).
  • Provision of technical support for process impurity assays (e.g. residual host cell protein (HCP), residual DNA (PCR techniques) and residual Protein A).
  • Provide technical leadership to the bioassay area personnel.
  • Analytical technology transfer, including Bioassay co-validation/qualification.
  • Perform, design and direct bench experiments as required
  • Troubleshooting and investigations.
  • Drive continuous improvement initiatives, including bioassay optimisation
  • Technical coaching/training of area personnel.
  • Technical liaison with Bioassay Method Development Group, QC department, Manufacturing, external vendors and 3rd level institutions/relevant government bodies.
  • Remain current with regard to cell biology, bioassay methodologies, technology and equipment,.
  • Independently write SOP’s, protocols, reports and input to IMPD/IND regulatory filing documents.
  • Supports the Manager for anticipating and planning future requirements in the area
  • Contribute to area management operational and strategic initiatives.
  • Presents technical analytical data clearly and concisely to customer’s i.e. internal and external regulatory inspections.
  • Ensure compliance with applicable cGMP and other business compliance regulations.
  • Participate in risk assessments, inspections, audits, etc. and implement and follow-up corrective/preventative actions as assigned.

Key Skills and Competencies required:
  • Expertise in cell biology/cell culture/cell based and binding biological assays
  • Knowledge of host cell proteins and assays related to their detection and characterization would be advantageous for this role.
  • Analytical Technology Transfer (equipment procurement and qualification, bioassay method qualification/validation)
  • Strong problem solving skills
  • Proficient in Bioassay data reduction, reporting and statistical analysis using Excel, Minitab etc.
  • Experimental design, including DOE, bioassay/ process impurity development
  • Automation (e.g Tecan) and 6S
  • Very strong communication skills (verbal, written & presentation)
  • Project management
  • Continuous improvement
  • Familiar with applicable cGMP and other business compliance regulations
  • Demonstrate capabilities in strategic thinking
  • Customer focus and results and performance driven
  • Sense of Urgency
  • Ability to work well within team structures and provide leadership.

Education and Experience:
  • A minimum of a Masters or PhD degree in Cell/Molecular Biology, Biochemistry, Pharmacy or related scientific field is required.
  • Practical analytical laboratory experience in a GLP/GMP environment is advantageous.

For further information on this Senior Associate Scientist role in Cork please contact Caroline Kingston on 0868395531 / caroline@hero.ie
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