Lilly Ongoing Interest - Talent in Analytical Scientist/Chemist/Microbiology in Kinsale, Ireland
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Owing to the continuous growth of our Eli Lilly, Kinsale facility in both the Large Molecule/Biologics space as well as Small Molecule/Pharmaceutical we are always open to and eager for talented individuals to join our team(s) and contribute to our goal of making a difference to people’s lives.
If you are looking for a challenging, rewarding career and feel you meet the requirements listed below we would love to consider you for a role at Eli Lilly, Kinsale.
The Analytical Scientist/Chemist/Microbiology roles in Quality Control provides the analytical technical leadership for all aspects of analytical technologies and methods. The roles 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 roles. The assets involved may be small molecules, peptides, or therapeutic proteins 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 roles 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.
Analytical Chemist Support:
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.
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.
Proactively support management decisions and strategy and be a role model for 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.
Pre-Requisites (Includes experience, qualification etc.)
Deep technical expertise in analytical chemistry/biochemistry/microbiological techniques, such as separation sciences, spectroscopy, mass spectrometry techniques, immunoassays, bioburden techniques
With safety as the priority, excellent laboratory techniques
Proficiency in the use of multiple instrument platforms (e.g. Thermo, Agilent, Waters 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, Biochemistry, Microbiology) with at least 5 years pharmaceutical analytical chemistry experience or PhD/Post Doctorate Level in Analytical Science (Chemistry, Biochemistry, Microbiology) with preferred 3-5 years of recent bench experience in a laboratory 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
Business Knowledge: High performance in delivery of their work. Looks at better, simpler ways, takes initiative and will run proactively with actions. Demonstrated self-management, prioritisation, and organisational skills.
Learning agility and Curiosity: High learning agility and flexibility and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop, and implement solutions.
Positive Influence: Demonstrated ability to address issues as they arise and act accordingly. Trusted in the team to follow through on actions. Is interested in own performance and seeks feedback to improve.
Relationship Builder: Demonstrated ability to establish and maintain key relationships across all levels in the organisation.
Ability to lead people: Demonstrated ability to technically lead and motivate in a team environment. Demonstrated ability to influence peers and across functions.
Communication: Demonstrated strong communication skills, written and oral in 1:1 and group situations.
Decision Making: Demonstrated ability to be decisive and make well informed decisions for the benefit of the team. Demonstrated ability to collate required information and ask the appropriate questions of peers to get to the best solution.
Roles may be offered on either a permanent or fixed duration Lilly contract basis and can be discussed further at the early stages of the interview process.
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