Associate Director Analytical Development
This international company focuses on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. Since their founding they have focused on putting the patient first and this remains their priority as they continue to develop, acquire and commercialize new treatment options for patients with challenging conditions that no one else is tackling. Currently employing over 1000 staff globally with offices in the U.S. and Europe. They are a continually growing company with a broad portfolio and a very healthy pipeline. Due to continued expansion, this organisation are now looking to appoint a permanent Associate Director of Analytical Development to their growing team.
- Wide-ranging experience in analytical development with a strong background in both small / large molecule technologies and formulation / drug product development. Specific experience of oral solid dose development involving IR / DR / SR technologies would be advantageous.
- Develop and implement stability strategies in support of project development activities
- Demonstrated technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design to support analytical method development objectives
- Experience of CMC regulatory requirements for pharmaceutical products and in particular the evolving opportunities offered by application of QbD principles to analytical method development.
- Directs and leads the activities of a department and / or cross functional teams
- Clearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiences.
- Support other Product/Process Development and Manufacturing areas to ensure a smooth transfer of technologies and products to contract sites.
- Planning, executing and reporting for all development projects and technology transfers in support of process improvement and new product introductions.
- Keep current with developments in analytical technology and methods and make recommendation for implementation in programs as appropriate
- Working closely with all leaders to monitor and where necessary, implement improvement initiatives in line with continuous improvement philosophy
- Bachelor’s degree with a masters or PhD in analytical science or equivalent
- Strong record of achievement in analytical development within a pharmaceutical development and manufacturing environment.
- Over ten years of experience required with a broad but detailed experience across analytical technologies
- Significant experience in either small or large molecule technologies, and a broad exposure to multiple drug delivery technologies and dosage forms
- Demonstrated technical expertise in process development and new product introduction
- Demonstrated track record of training and coaching colleagues to improve overall team process knowledge.
- Demonstrated track record of delivering positive results on a consistent basis.
- Proven project management skills for technical programs
- Experience in defending processes, procedures and investigation during FDA/EMA inspections desirable.
- You will be capable of grasping complex technical issues and make sound decisions based on data and information from various sources
- Track record of success in cross functional collaboration
To learn more apply on line or call Shane Browne on +353 1 6321865.
Salary: On Application
Location: Dublin South