- Conducting various analytical testing as specified above (including second person verification) in accordance with cGMPs
- Maintaining the laboratory facility, supplies and equipment in an inspection-ready state, and supporting regulatory inspections where required
- Conducting and documenting Quality observations and investigations to completion
- Tabulating and consolidating assay results, lead times and other performance indicators and presenting informal reports of results to immediate supervision
- Using Lean methodologies and participating in continuous improvement projects
- Participating in laboratory and facility processes including safety audits, procedure revision, housekeeping and improvement projects, and liaising with other departments as necessary
- Qualification and routine maintenance of various analytical instrumentation including PAT (Process Analytical Technology)
- Development, validation and verification of new methodologies as part of new product introductions or process improvement activities
- Acting as a technical resource (subject matter expert) for analytical technologies
- Training of other personnel in Analytical techniques
- Adhering to Environmental, Health and Safety (HSE) procedures and involvement in HSE incident investigations as needed
- Strong technical aptitude and willingness to learn new tasks/technology
- Ability to work independently, own tasks and training, and problem solve/troubleshoot
- Strong collaborative skills with an ability to work effectively in a team environment
- Excellent communication (written, oral, listening) skills
- Excellent attention to detail and accuracy in execution
- Customer focus - takes personal responsibility for speed, quality and accuracy of delivery
- Self-motivated, positive and ability to work under pressure
Sr. Laboratory Analyst - Kinsale, Ireland - Lilly
Description
We're looking for people who are determined to make life better for people around the world.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
We currently have multiple openings for Sr. Laboratory Analyst positions within the Quality Control Laboratory analytical teams at Eli Lilly Kinsale. These positions are permanent roles based at the Kinsale site and are across multiple analytical groups supporting Peptides, Small Molecule and Large Molecule/Biotech manufacturing at the site.
As a member of the Quality Control Laboratory, the Sr. Laboratory Analyst is primarily responsible for conducting various analytical tests/assays to determine the identity, quality and purity of various pharmaceutical-related analytes including raw materials, intermediates, final products/batch release, stability samples, reference standard characterisation, investigative/non-routine samples etc., and/or validation of new methods to support new product introductions (NPIs). All work is conducted in accordance with current Good Manufacturing Practice (cGMP) requirements. Typical analytical techniques and equipment utilised as part of the role would include high performance liquid chromatography (including online HPLC/PATrols), gas chromatography, capillary electrophoresis, UV spectrophotometry, atomic absorption spectrometry, Inductively Coupled Plasma spectrometry, particle size analysers, Karl Fischer titrators, mass spectrometry (LCMS), and IR and NMR spectrometry.
The Sr. Laboratory Analyst will normally work under the technical supervision of an Analytical Chemist, who will provide technical oversight for the analytical testing. A subset of the Laboratory Analysts within the department will be working on a shift basis depending on production support needs.
You must meet the minimum qualifications outlined in the Educational Requirements section and have/obtain work authorisation in Ireland to be considered for the role.
Reporting To:
Senior Manager-Analytical
Educational Requirements:
Minimum Hons BSc in Analytical Chemistry, Chemistry, Biochemistry or a related Laboratory Science subject required.
Additional Requirements:
Experience with the analytical methodology specified above within a GMP setting is highly desirable/a distinct advantage.
Key responsibilities for the role may include:
Key Attributes for the role:
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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