Ref No: AM17236
Cork, Co. Cork, Ireland
Analytical Technical Steward - County Cork.
This role is sited in the API External Manufacturing Quality Control Laboratory, and is a technical position helping to ensure that the analytical testing of products at multiple contract manufacturing (CM) sites meets both company and external requirements, and is executed consistently to predetermined standards.
The position is fast-paced, with multiple activities occurring simultaneously at potentially multiple CM sites. The Analytical Technical Steward reviews data released by the contract manufacturer to ensure it meets expectations, reviews deviations for trends, reviews and/or releases stability data, and leads the resolution of laboratory related manufacturing issues by performing in-depth problem solving. Proactively identifies opportunities for continuous improvement, and completes thorough investigations of aberrant data and results. You may perform non-routine lab work in support of this.
Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional post-launch process optimisation teams. The Analytical Technical Steward works closely with development to ensure robust analytical control strategies are established in QC.
Key Objectives of this role:
• Technical review, interpretation, and release of data, including release data, from CM, stability, process validation, and reference standard characterisation.
• Utilises technical skills to lead or perform in-depth investigations into out of specification results and aberrant data. Guides CM's to perform root cause analysis investigations and develop solutions to prevent reoccurrence.
• Develop investigational testing protocols and perform testing as required.
• Contribute to annual product review and process validation as required.
• Communicate effectively in both written and oral formats within the lab as well as with CM's and business partners.
• Participates in internal/external audits as needed
• Co-ordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing.
• Method assessments, deficiencies and areas for improvement noted within the assessments.
• Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed.
• Method validations (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in laboratory practices).
• Review of analytical test method packages
• Approval of test method protocols
• Approval of new test methods or changes or deletions to existing test methods
• Provide laboratory support (e.g. method development, validation and method development work, and implementation of method improvements for marketed products).
• Implement new technologies into the CM Labs and improve existing methodologies.
• Improve assays in the CM Labs. These improvements include variability reduction, method optimisation, and new method development.
• Local and Global Method Change Control Ownership
• Oversight over reference standard evaluations
• Selection of appropriate packaging materials
• Participate in the review of the reference standard profile and associated documentation for data integrity
• Consult in the preparation of the characterisation protocol for corporate reference standards
• Approve the characterisation protocol before the initiation of laboratory testing of candidate materials for corporate reference standards
• Method transfers between QC labs and to CMs
• Oversee transfer of analytical methods for marketed products to CM's or other QC Labs.
• Monograph review and implementation
• Ensure consistent practices between global laboratories.
• Effective management of multiple projects.
Interested applicants should be able to:
• Demonstrate proficiency in complex laboratory analysis in a cGMP laboratory, including, but not limited to chromatographic, spectroscopic, and/or microbiological assays.
• Have at least 5 years’ experience supporting analytical aspects of monoclonal antibody clinical trial development and/or manufacturing
• Strong skills in making risk-based decisions and prioritisation
• Deep understanding of cGMP compliance requirements and regulatory expectations
• Demonstrated accuracy and proficiency in analytical skills
• Demonstrated strong problem-solving skills.
• Strong oral and written communication skills, demonstrated through documentation and presentation skills
• Demonstrated strong interpersonal interaction skills
• Demonstrated experience with method qualification and validation
Ideally (not essentially) you will have:
• Previous experience working with contract laboratories in a cGMP environment
• Training and demonstrated proficiency in root cause analysis methodology
Bachelor degree (4 year university) in a science field related to the lab (e.g. Chemistry, Biochemistry, Biology)