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Details

Senior Scientist (Analytical Operations)


Reference:KS/ABNB-256401 Location: Cork
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed

Our client is a global leader in the Pharmaceutical Sector, based in Cork. They are currently seeking a Senior Scientist for their Analytical Operations team. The person will have a strong background in Dissolution, HPLC, KF, UPLC and who has extensive experience of LIMS. An advanced qualification in Chemistry or Biology coupled with a minimum of 5+ years analytical & drug product testing experience is essential. Experience of API & Drug Product desired. This is a Senior role on the team so the successful person will be very strong on communication within the group & preparing the junior members of the team for new processes that they will be implementing as & when they are required.

Role/Responsibilities:

  • Advanced level of understanding of analytical methods.
  • Selects appropriate methods and techniques in performing method developments.
  • Independently plans and executes experiments that support routine & non-routine development activities and project goals.
  • Collaborates within our client’s labs & contract test labs to develop & validate methods.
  • May design new experiments to support development of drug substances and drug products or techniques to test such substances.
  • May create API or drug product specifications.
  • Generation, review and approval of development & validation lifecycle documentation including change controls, risk assessments, protocols, reports etc
  • Collation of data and technical writing for submissions for regulatory filings.
  • Planning and execution of method transfer/validations, process, cleaning and analytical testing in accordance with validation protocols
  • Operates as part of a global sub team as an AO lead
  • Recommends alternatives, researches new methods and techniques and may proactively seek out senior personnel to discuss potential solutions to problems.
  • Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
  • Works independently and determines methods and techniques on new or difficult assignments.
  • Works on complex problems where analysis of situations or data requires comprehensive evaluation of many factors.
  • Acts as a resource for other employees within the department.
  • Task management of junior employees may be required
  • Manage group with multiple areas of responsibility.
  • Identifies and introduces new technology and/or methods to the organization and trains junior staff.

Education/Experience:

  • BA or BSc degree in Chemistry or Biology with 10+ years experience/ MSc degree in Chemistry or Biology with 8+ years experience/ PhD with Industry exp in analytical & drug product testing
  • Competent in the operation of Analytical Instrumentation including Dissolution Baths, KF, UPLC & HPLC proficient in LIMS & Empower etc.
  • Resilient & dynamic profile with the ability to deliver
  • Ability to engage and manage multiple stakeholders to achieve the objective
  • Organised with systematic approach to prioritisation; Process orientated to achieve the business objective
  • Developed skills in data analysis and ability to evaluate quality of data.
  • Maintains high level of expertise through familiarity with scientific literature and applies appropriately to development projects. Has scientific expertise and ability to think ahead to the next step in drug development process.
  • Uses strong communication skills (both verbal and technical) and interpersonal skills to communicate objectives and results.
  • Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
  • Working knowledge of GMPs, pharmacopoeia, regulatory requirements for analytical testing, phase appropriate standards for method validation.
  • Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs).


For further details please contact Karen Shiel in confidence on: 01 5079256/ 087 7452487 or email CV to karen.shiel@lifescience.ie and I shall call you to discuss the role in detail.