Responsibilities:

• Overall responsibility for global drug product manufacturing
• Responsible for continuous improvement throughout drug product manufacturing, including process validation up to commercialization
• Support cross-functional project teams and work closely with Analytical Sciences and Stability, Quality Assurance, Clinical Supply Chain, and Regulatory as well as external Contract Organizations to ensure timely and effective execution of related tasks
• Provide supplier technical management and oversight
• Provide technical project management support for all clinical drug product manufacturing activities including batch record reviews
• Author/review manufacturing documents and support regulatory submissions, responses and inspections
• Author review protocols, technical reports, articles and portions of regulatory submissions
• Proactively identify potential issues and develop creative solutions to technical problems in order to keep projects on schedule with great technical probability of success
• Identify and manage process improvement activities for clinical manufacturing operations
• Coordinate and develop business processes related to the transfer of drug product processes from the development site to the manufacturing site
• Travel: Up to 20%

Requirements:

• Education plus experience: PhD plus a minimum of 3 years’ experience or BS/MS plus a minimum of 6 years’ experience. Degree in chemical or pharmaceutical engineering is strongly preferred
• Experience managing technology transfer operations and process capability studies within the pharmaceutical industry is required; oncology drug development for parenteral and oral products specifically is strongly preferred
• Demonstrated technical project management and/or project leadership experience to develop integrated short-term and long-term project plans
• Extensive experience with DOE, FMEA, GMP, etc. is desirable