Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds. This newly created role, Associate Director, Process Development will rreport to the Senior Director Technical Operations and will provide scientific and technical leadership to external commercial partners for large and/or small molecule DS/DP.
This position is responsible for providing strong scientific leadership for all aspects of technology transfer, process scale-up, process monitoring, and process troubleshooting to drug substance, drug product and finished product manufacturing activities for large and/or small molecules. This responsibility includes all process validation activities. Other responsibilities will include cross-functional team leadership and / or membership, authoring technical reports and supporting CMC aspects of regulatory dossiers. The role will involve significant cross functional collaboration with other functions including R&D, external manufacturing and Quality, working towards existing and new product introduction and ensuring all processes are understood, robust, efficient and in control.
- Lead development, maintenance and continuous improvement of process validation program for all DS and DP manufacturing processes. Provide technical input to Process Development for defining the critical process parameters of new processes
- Experience of CMC regulatory requirements for pharmaceutical products and the evolving opportunities offered by application of QbD principles
- Direct and lead the activities and / or participate in 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.
- Ensure that all processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and procedures.
- Take ownership of planning, executing and reporting for all development projects and technology transfers in support of process improvement and new product introductions.
- Develop knowledge of new pharmaceutical manufacturing processes as required in line with Company business objectives
- Highly flexible, works well in a team environment, and has necessary skills to organize, mobilize, communicate, influence and lead.
- Unquestionable level of integrity
- Excellent critical thinking and problem solving abilities. Must be capable of grasping complex technical issues and making sound decisions based on the fundamental principles of the technology, the data, and applicable business and strategic issues
- 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 in relevant scientific discipline, advanced degree (MSc, PhD) desirable.
- Strong record of achievement in pharmaceutical manufacturing environment. Wide-ranging experience in pharmaceutical manufacturing with a strong background in large and/or small molecule technologies.
- Demonstrated technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design to support process development/ support objectives
- Proven hands-on experience in GMP manufacturing and validation activities
- Experience in process characterization and development to identify process boundaries and critical process parameters
- Experience of both small and/or large molecule technologies, with 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 ideally complemented with Project Management qualification.
- Experience in defending processes, procedures and investigations during FDA/EMA inspections is desirable
Cv to email@example.com 01 2302400 www.rftgroup.ie
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