Raleigh, NC, inhalation company. This position involves managing the R&D MDI processing laboratory at our client’s Raleigh, NC site. The primary functions will be to lead the development and scale-up of the MDI filling process, including identifying or developing appropriate equipment, managing internal and external resources and managing relations with a contract manufacturing partner. Additional responsibilities include oversight of the spray drying and micronization team at our Redwood City, CA site.
Responsibilities
• Manage the R&D MDI process development team, suite and associated equipment
• Develop and implement a strategy for commercial particle production
• Author and review manufacturing sections of regulatory documents , including INDs and NDAs
• Evaluate and develop MDI filling processes
• Identify 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 with a contract manufacturing partner
• Identify and work with vendors and contract organizations
• Investigate and understand interactions of company particles and formulations with filling equipment and the filling process
• Oversee the Particle Engineering and Micronization function at our Redwood City facility, including process development and scale-up activities
• Participate in product development teams and other project meetings as necessary
• Develop and implement PAT for on-line measurements and control of production
• Identify opportunities for quality enhancement and improvements to operational efficiencies and develop efficient methodologies to track progress.
Requirements
• PhD in Engineering, Pharmaceutics or Chemistry with 5+ years of experience or MS/BA with 7+/10+ years of MDI filling and process development experience, including HFAs, in a fully GMP and GLP compliant environment
• Expertise with Pamasol and other MDI filling equipment
• Experience in particle engineering a plus
• Expertise related to propellant and particle interactions with materials, equipment and container closure systems desirable
• Experience with spray drying a plus
• Experience with PAT, QbD and lean manufacturing practices is highly desirable
• Proven ability to work with multiple teams at multiple locations
• Ability to communicate effectively, make presentations and write concise reports for senior management and all levels of employees
• Travel ~35% between the California and North Carolina research sites and contract facilities as necessary.
Physical Demands & Work Environment
Must be able to operate a PC and sit and stand for extended periods of time. Some lifting required (not more than 50 lbs.). Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position description intends to describe the general nature and level of work being performed by people assigned to this job. It is not intended to include all duties and responsibilities. The order in which duties and responsibilities are listed is not significant.
For more information, contact Pam Gowda at pamgowda@kineticsearch.com
