Berkley Pharma & Life Science are currently seeking a Blending & Micronisation Manager for our client a Global pharmaceutical company based in Dublin.
Ref: 5040176
Role/Opportunity:
• An experienced Process Development Scientist or Pharmaceutical Engineer responsible for leading and managing the blending and micronisation process development and clinical manufacturing operations the Pilot Plant facility.
• Works with other R&D colleagues on Dry Powder Inhalation (DPI) development projects to design and execute product development activities and technical transfer of new products into the pilot plant in Dublin and subsequently into the Commercial facility.
• Manages matrix team and schedules activities for micronisation and blending development for both product development and clinical manufacturing programmes. Delivers high quality results within a cGMP environment.
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
• A deep understanding of powder blending and/or micronisation processes and equipment used for manufacture of powder systems used in an R&D and/or a GMP manufacturing environment (inhaled product development preferred).
• Contemporary understanding of cGMP regulations/guidance in relation to all aspects of clinical manufacturing and a solid grasp of relevant scientific and technical aspects of role.
• Experience of clinical trials manufacture to cGMP and process development and scale-up of dry powder pharmaceutical systems is required (inhaled product development experience preferred).
• Experience of Technical Transfer of products and processes into a commercial manufacturing environment is desirable.
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 Steve Burke on +353 (0)1 8724666 or send your CV to science@berkley-group.com
