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 / firstname.lastname@example.org
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