The client is a privately held specialty biotech company focused on developing combination therapies in the respiratory, pulmonary, and asthma areas.
This position will involve set up and operation of an MDI processing laboratory. The primary functions will be to develop and scale-up MDI filling processes, including identifying or developing appropriate equipment, managing internal and external resources.
** Qualified candidates must have MDI and commercial experience! **
Responsibilities
• Manage and maintain the MDI process development suite and associated equipment
• Develop MDI filling processes
• Define and source appropriate equipment
• Manage batch filling operations for R&D and GLP supplies and manage external contractors for both GLP and GMP manufacturing
• Develop and manage process scale up activities
• Identify and work with vendors and contract organizations
• Investigate and understand interactions of Pearl particles and formulations with filling equipment and the filling process
• Coordinate with Particle Engineering, Process & Scale-Up, Product Development and various Project Teams as needed
• Develop and implement PAT for on-line measurements and control of production
Requirements
• PhD in Engineering, Pharmaceutics or Chemistry with 5+ years of experience or BA/MS with 10+/7+ years of MDI filling and process development experience, including HFAs, in a fully GMP and G:P compliant environment
• Expertise with Pamasol and other MDI filling equipment
• Expert knowledge of propellant and particle interactions with materials, equipment and container closure systems
• Experience with PAT and QbD practices is desirable
• Excellent written and oral communication skills are necessary
• Ability to work with multiple teams at multiple sites is critical
Please contact mtrail@taylor-strategy.com for details.
