• Lead and coordinate transfer of analytical methods to support new product introduction• Supporting QC Laboratory in the release of Raw Materials, Finished Bulk and Packed product and also coordinated the Stability Testing Program• Technical review of change controls to assess suitability for filing of variations with agencies• Management of Quality compliance through monitoring and tracking metrics for closure on time rate of investigations, CAPA’s and deviations• Responsible for ensuring Laboratory audit readiness and for presenting in agency site inspections• Coaching, mentoring and performance assessment of laboratory team members with implementation of robust Individual Development Plans (IDP’s)

• Provided technical support to QC Laboratory through troubleshooting and investigation of problematic methods and processes• Reviewed all analytical methods and method validations for compliance with regulatory guidelines, compilation of gap assessments and remedial plan with timelines for completion• Led new API supplier introduction as part of new product transfers and second source API projects to support site cost reductions

• Responsible for management of Investigational Medicinal Product (IMP) product specification files and shipments for Clinical Trials• Compiled clinical drug product release documentation and Module 3 dossier submissions• Co-ordinated R&D full ICH stability studies to support new drug product submissions

• Responsible for project management of the analytical aspects of several R&D drug products• Authored and approved analytical protocols, reports, test methods and specifications for drug submissions.• Provided technical support for response to agency questions

• Empower Administration, created and validated report templates• Training coordinator, trained analysts and facilitated external courses• Purchased laboratory consumables and equipment

• Laboratory instrumentation calibration and troubleshooting• Tested in-process, release, and stability drug product samples• Developed and validated analytical methods according to ICH guidelines