Analytical Development, Associate Director Dublin
Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research. This newly created role will join the Technical Development team.
The role will provide scientific and technical leadership at various stages of drug development including analytical method assessment, development, transfer, validation and troubleshooting. Activities will cover both drug substance (small and large molecule) and drug products. Success requires application of scientific principles and creativity to process / analytical design and development studies, and translation into commercially feasible, reliable and robust methods for both drug substance and product. Activities may be performed internally or with external vendors.
Other responsibilities may include cross-functional team leadership and / or membership. Authoring and / or reviewing method validation protocols and reports, technical reports, supporting CMC aspects of regulatory dossiers. The role will involve significant cross functional collaboration with other functions including R&D, Manufacturing and Quality, working towards agile new product introduction and ensuring all processes are understood, robust, efficient and in control.
The role is primarily development project related but may also support commercial products. It shall require an ability to drive and deliver multiple projects.
Job Spec :
•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
Person Spec :
•Highly flexible, works well in a team environment, and has necessary skills to organize, mobilize, communicate, influence and lead.
•Unquestionable level of integrity
•Demonstrated capability in establishing collaborative working relationships at all levels, regardless of seniority
•Demonstrated communication excellence through multiple mediums
•Quick to recognize areas for improvement, and use initiative to implement change programs in support of progress
•Ability to deliver objectives on time in pressurized, fast paced environment, whilst also meeting all compliance , quality and cost targets
•Through leading by example, support culture of collaboration, participation and knowledge development among the team.
•Actively support at all levels, cascaded culture of change, innovation and self- improvement to reach all levels of work force.
•Current knowledge of quality systems and both FDA and EU regulations as they relate to process / product development and manufacturing
•Knowledge and experience of working with statistical process control techniques in an operational excellence environment
•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 of both small and 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
Cv to email@example.com 01 2302400 www.rftgroup.ie