Our client a global pharmaceutical company are currently seeking an Assembly & Packaging Manager to join their organisation.
Ref: 5040178
Role/Opportunity:
• Device assembly and/or packaging engineer responsible for leading and managing the final drug-device assembly and packaging clinical operations in line with Good Manufacturing Practice (GMP) requirements within the R&D Pilot Plant facility.
• Works with other R&D colleagues on inhaler development projects to execute process development activities and technical transfer of new products into the pilot plant in Dublin, Ireland from the UK and subsequently into the co-located Commercial Facility.
• Manages a team of operators and schedules activities for assembly and packaging operations into overall clinical manufacturing and development programs.
• Produces high quality results within a cGMP environment for the team. Works with external parties to support the development of the device and packaging needs for the inhaler program, and in the transfer of technical and operational process and product development understanding in to the Commercial Facility.
• Also operates closely with manufacturing organisations in establishing the commercial technology platform.
• Thorough understanding of bespoke pharmaceutical engineering equipment used for assembly and packaging operations in an R&D and/or a GMP manufacturing environment. Understanding of the impact of assembly and packaging processes on product performance.
• Experience of device assembly and packaging development activities and operations for device systems (inhalation product development preferred) in a GMP environment.
• Leadership of projects or teams in a device or pharmaceutical environment.
• Practical experience of device development activities.
• Experience of Technical Transfer of products and processes into a Commercial Manufacturing facility.
Skills/Experience:
• Minimum of a third level qualification in Chemistry or related discipline
• At least 5 years relevant technical experience in a highly regulated environment (IMB/FDA)
• Track record in managing and motivating a team and delivering results through people.
• An understanding of Lean Principles/Operational Excellence tools and “hands on” implementation of same in a pharmaceutical environment
• Strong organisational skills with the ability to multitask and prioritise workload in a fast moving environment
• Excellent verbal, written and interpersonal communication skills with the ability to interact effectively at all levels within the organisation
Berkley Pharmaceutical and Life Sciences is a specialist recruitment consultancy which recruits pharmaceutical, clinical and medical device professionals throughout Ireland, Asia, UK and Australia
For more information go to http://www.berkley-group.com
To apply: If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Sinéad Hawes on +353 (0)1 8724667 or send your CV to science@berkley-group.com
