The site is welcoming exciting growth and new expansions to support much-needed capacity for APIs currently in development and the growing needs of customers and the patients they serve.
The Senior Analytical Development (AD) Chemist will function as a key member of the AD Team and will report to the ADManager. You will be key to the introduction of new products to the Cork site.
Duties and Responsibilities :
· You will promote and monitor laboratory GMP / Safety within the AD group.
· Provide analytical expertise and support for the introduction of new products to the Site, including method assessment, method development, validation/qualification and transfer.
· Be the lead analyst on projects. Plan the execution of the projects and mentor/lead the support analysts.
· Project/people management for technology transfer projects.
· Lead troubleshooting activities during the development, validation/qualification and transfer of methods. Plan, complete and evaluate fate of impurities studies in collaboration with colleagues and client through interpretation of analytical data and adhering to current and emerging regulatory strategies (quality by design, GMP, ICH’s guidelines) for API.
· Communicate regularly with the clients and internal partners, providing updates on projects progress, hosting clients visits, addressing technical queries and delivering client project requirements to the defined timelines.
· Responsible for managing employees and resources to ensure the delivery of projects in the required timeframe and ensure that the site’s technical, quality and safety metrics are all achieved.
· Prepare, review and approve change controls, protocols, project status report, final reports and other internal documentation relevant to the role.
· Present training sessions to QC and provide technical support during method familiarisation period.
· Work with due care and attention, perform all quality, regulatory and safety duties in a compliant manner whilst acting always in accordance with the Dignity at Work Policy, Code of Business Conduct and Ethics and our values of Integrity, Intensity, Innovation and Involvement.
· Develop/Expand scientific, technical knowledge by reading the peer reviewed scientific literature, attending scientific conferences via relevant training.
· BSc; Masters or PhD in relevant scientific field with significant experience in industry or academia.
· Experience in analytical method development, validation and analytical technology transfer within the pharmaceutical industry.
· Project/people management experience for technology transfer projects
· Experience with HPLC, UHPLC, GC, LC/MS, GC/Headspace, GC/MS, UV, IR, KF, ion chromatography and ICP.
· Empower experience.
For a confidential discussion and more information on the role, please contact Rory Walsh.