Our client is a subsidiary of a global pharmaceutical corporation with a portfolio of products in the ocular, auto-immune and cardiac categories. Based in Limerick, and as part of the expansion of its operations in Ireland we have been retained to source candidates for the position of Senior Manager for QC Chemistry.
The successful candidate will lead the laboratory QC testing of in-process, stability and final drug products. The will have technical responsibility for all chemical aspects of QC testing, leading staff of in excess of 50 professionals in an expanding company.
Key aspects of the job will include:
Brings a high-level operational focus to supporting the Manufacturing, Stability, and Business Operations with analytical services. Responsible through their own supervisory structures for staffing levels, work scheduling and troubleshooting issues to support same and maintain compliance.
Manage QC Chemistry operations to maintain services and introduce improvements where identified.
Reviews test reports, provide oversight and technical leadership where required. This extends to investigating atypical and OOS test results as necessary.
Manage the laboratories to ensure that QC Analysts receive proper training, safety standards are maintained, and compliance with applicable cGMP regulations and SOPs is guaranteed.
Manage assay transfer internally from R&D to the QC laboratory or from PAS to the QC laboratory as well as managing assay transfer externally from QC laboratory to contract labs, including audits if needed.
Oversee QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness.
Candidates will have a BSc. in chemistry, biology or related field with 8+ years’ relevant experience (pharmaceutical or biotechnology industry) in laboratory management and analytical sciences. They will have a thorough understanding of analytical testing in a cGMP environment for Raw Materials, Wet Chemistry, and HPLC assays. They will also be familiar with LIMS.
Given the scale of the QC operations, candidates must have worked in a responsible management or senior supervisory or management role in a large laboratory, with at least 5 years’ experience in a management or supervisory position.
Exposure to lean laboratories is desirable as is experience of managing vendor services provided by contract laboratories
For further information on this role, please contact Liam McDonnell at Harty Search & Selection;
Office – 061-414533