Senior Analytical Scientist
Eli Lilly
- Kinsale, Co Cork
- Permanent
- Full-time
- 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.
- As required 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.
- Will assure that 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
- Be a role model for Analytical Sciences/Quality Control team members in terms of performance and behaviours
- Influence the Business/ external partners on critical issues to meet end goals – understand the external context/environment to achieve these goals
- Attend and contribute to relevant technical fora.
- Proactively support management decisions and strategy
- Deep technical expertise in analytical chemistry techniques, in particular in separation sciences, biophysical and mass spectrometry techniques.
- With safety as the priority excellent laboratory techniques
- Proficiency in the use of multiple instrument platforms (e.g. Thermo, Agilent, etc.)
- Strong technical problem-solving ability both independently and as part of a team.
- Motivated to work independently to produce high quality work product in an efficient manner.
- High attention to detail in all aspects of the work.
- 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.
- High learning agility and flexibility to achieve the required outcomes.
- Strong written and oral communication skills
- Working knowledge in one or more of the following chemical, peptide or protein synthesis
- Development and implementation of multi-attribute methods (PAT or offline)
- Imaginative approach to problem solving and solution discovery
- Ability to resolve conflict, and promote good decision making among team members