Associate Director Principal Engineer
Core
Provide technical leadership and support for process manufacturing of oral solid dose (tablet and capsule) pharmaceutical products, including troubleshooting, technology transfer, and process validation.
Role type
Senior IC process engineering lead (pharmaceutical manufacturing)
Builds
Robust and efficient manufacturing processes for commercialization of new and existing products
Domain
Pharmaceutical manufacturing (Oral Solid Dose)
Required skills
Process engineering, cGMP compliance, technology transfer, process validation, root-cause analysis, scale-up, statistical process control, equipment modification, project management
Preferred skills
Lean Manufacturing, Six Sigma, IQ/OQ/PQ, Statistical Process Control, Process Capability Analysis
Technologies
Process Analytical Technologies (PAT), cGMP, GAMP, ITIL, PMI
Responsibilities
Lead technology transfer and implementation of new technologies, equipment, and processes from R&D and other sites; Investigate and correct process-related problems and deviations from standards; Design and execute Process Validation Studies supporting commercialization; Conduct statistical process control and process capability analyses; Justify processing parameters and conduct scale-up activities; Train and mentor new Process Engineers and interns.
Seniority
Senior, hands-on IC with management responsibilities
