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Senior Scientist (Bioassay)

  • Job reference: 930181
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: R&D - Clinical & Non Clinical, Life Sciences
  • Date posted: 24/02/2020

Orion Group Life Sciences have an exciting opportunity for a Senior Scientist (Bioassay) for our Multinational Pharmaceutical client based in the Cork area on an initial 10-month contract.


Job Purpose

Reporting to the Bioassay Team Lead in Cork, the person will support a number of bioassay and process impurity techniques providing support for troubleshooting, investigations and trending. The person may also be responsible for analytical method transfer of new methods and analytical techniques into the department to support new clinical molecules. The person may also support clinical molecules for stability studies, authoring protocols, trending and assignment of shelf life.

Main Responsibilities of the role

  • Provision of bioassay technical support for a wide range of bioassay methods and techniques (ELISA, cell based assays, FRET and residual process impurity assays)
  • Provide technical leadership to the bioassay area personnel
  • Leadership and technical support of analytical method transfer for bioassay methods including qualification and validation of assays
  • Perform, design and direct bench experiments as required
  • Troubleshooting and investigations
  • Drive continuous improvement initiatives
  • Technical coaching/training of area personnel
  • Technical liaison with other teams and departments within Bio team, QC department, Manufacturing, external vendors and 3rd level institutions
  • Remain current with regard to cell biology, bioassay methodologies, technology and equipment
  • Independently write protocols, reports and input to IMPD/IND regulatory filing documents
  • Presents technical analytical data clearly and concisely to partners and customers
  • 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

Desired Experience and Background of the successful candidate

  • 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
  • Expertise in cell biology/cell culture/cell based and binding biological assays
  • Knowledge of residual process impuities techiques 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 would be advantageous
  • Very strong communication skills (verbal, written & presentation)
  • Project management
  • Demonstration of previous Continuous improvement projects/initiatives
  • Familiar with applicable cGMP and other business compliance regulations
  • Demonstrate capabilities in strategic thinking
  • Ability to work well within team structures and provide leadership

#pharmaceutical #medical #multinational #product #scientist #bioassay #GMP

For more information on this role, call Daniel Ryan on +353868140295 or email Daniel.Ryan@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 930181


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.