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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Senior Analytical Scientist


Reference:SCA014648 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Analytical Chemist, Analytical Group Leader

Senior Analytical Scientist
Our client, a global pharma company, are currently recruiting for a Senior Analytical Scientist to join their team on a permanent basis. As Senior Analytical Scientist, you will provide analytical leadership for all aspects of advanced analytical technologies and methods within the Analytical sciences/Quality control characterisation area.

Role overview:
As Senior Analytical Scientist you will be responsible for provision of analytical methods, data and information using analytical techniques in supporting site manufacturing processes and network projects. The development and validation of the methods and their associated lifecycle will be a key aspect of the role.The assets involved may be small molecules, peptides, therapeutic proteins, drug conjugates and gene therapies within the new product introduction or commercial environment. The lifecycle management of existing technologies and instrumentation will be a further aspect of these roles. Given the increasing need for more in-depth molecule information and the increasing complexity of assets the identification of and implementation of new or improved technologies will be required.

The role will be responsible for all the information generated that will be used to support manufacturing objectives. The active participation in cross functional teams within the internal/external manufacturing sites and development will be required to understand manufacturing and regulatory requirements while also providing the analytical technical leadership and perspective to meet the manufacturing goals.

Responsibilities:

  • Support the introduction, validation and on-going technical agenda for pipeline and commercial analytical methods and technology
  • Develop and validate robust scientifically advanced methods with the required performance attributes to satisfy stakeholder needs
  • Execute and/or oversee testing protocols in accordance with local procedure and regulatory requirements.
  • Develop strong links with Global Regulatory Affairs and participate in the preparation and review of regulatory submissions
  • Provide training or mentorship to other QC or cross functional team members
  • Act as SME for one or more technologies and / or business systems within QC. This may include the identification, sourcing, installation, and qualification of new equipment
  • Ensure all raw materials, in-process samples, intermediates or final products are appropriately analyzed and authorised. In the event of non-conformance to acceptable quality and/or safety standards, lead analytical investigations, using Root Cause Analysis techniques where appropriate. Ensure all associated countermeasures are complete. Work with onsite technical teams to improve the state of validation and drive analytical variability reduction
  • Support the writing of Annual Product Reviews (APRs) on Active Pharmaceutical Ingredients and Laboratory Periodic Review Reports (PRRs)
  • Support and participate in self-inspection or other audits with particular reference to the analytical aspects of cGMPs as defined by the Health Authorities, Food and Drug Administration, etc

Requirements:
  • BSc/MSc Analytical Sciences (Chemistry or Biochemistry) with at least 5 years pharmaceutical analytical chemistry experience or PhD/Post Doctorate Level in Analytical Science (Chemistry or Biochemistry) with 3-5 years of recent bench experience in advanced analytics environment
  • Deep technical expertise in analytical chemistry techniques, in particular in separation sciences, biophysical and mass spectrometry techniques
  • Proficiency in the use of multiple instrument platforms (e.g. Thermo, Agilent, etc.)
  • High learning agility and flexibility to achieve the required outcomes
  • Working knowledge in one or more of the following chemical, peptide or protein synthesis
  • Development and implementation of multi-attribute methods (PAT or offline)
For more information please contact Sinéad Cullen on +353879500821 or [email protected]