Associate Director, API Process Development 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, Associate Director API Process Development will join the Biologics development team.
Reporting into the VP Technical Development (or delegate) the role will provide scientific and technical leadership for drug substance (primarily) development projects at various stages of the development life-cycle. Success requires application of scientific and/or engineering principles and creativity to process design and development studies, and translation into commercially feasible, reliable and robust processes. Experience of the critical interface attributes between drug substance and drug product will be especially relevant. Activities may be performed internally or with external vendors.
Other responsibilities will include cross-functional team leadership and / or membership, authoring 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 both project and operations orientated. It shall require an ability to drive and deliver multiple projects.
Wide-ranging experience in pharmaceutical development and manufacturing with a strong background in small / large molecule technologies. Knowledge of formulation development would be also advantageous.
Demonstrated technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design to support process development objectives
Experience of CMC regulatory requirements for pharmaceutical products and in particular the evolving opportunities offered by application of QbD principles
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.
Ensuring that all processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and procedures
Planning, executing and reporting for all development projects and technology transfers in support of process improvement and new product introductions.
Developing knowledge of new pharmaceutical manufacturing processes as required in line with business objectives
Working closely with all leaders to monitor and where necessary, implement improvement initiatives in line with continuous improvement philosophy
- 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 science or engineering
- Strong record of achievement in pharmaceutical development and manufacturing environment.
- Over ten years of experience required with a broad experience across drug development and manufacturing technologies but with specific experience related to drug substance development.
- Significant experience of both small and large molecule technologies, 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
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