Berkley Pharma & Life Science are currently seeking a Filling Manager for our client a Global pharmaceutical company based in Dublin.
Ref: 5040177
Role/Opportunity:
• An experienced Process Development Scientist or Engineer responsible for leading and managing filling process operations in line with Good Manufacturing Practice (GMP).
• Works with other R&D colleagues on DPI development projects to execute process development activities and technical transfer of new products into the pilot plant in and subsequently into the Commercial facility.
• Manages team and schedules activities for filling process development and clinical manufacturing programmes.
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
• Thorough understanding of pharmaceutical equipment used for unit dosing of powders in an R&D and/or a GMP manufacturing environment (complex filling equipment preferred).
• Experience of clinical trials manufacture to cGMP (inhaled product development experience preferred).
• Experience of process development and scale-up of dry powder pharmaceutical systems (inhalation product development preferred).
• Practical experience of inhaled drug product development (preferred) in a cGMP environment.
• Experience of Technical Transfer of products and processes into a commercial manufacturing environment.
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
