Provide interface with Development and Engineering in technology transfer of new processes as well as process upgrades to existing technologies. Act as manufacturing liaison in project planning and coordination. Design and execute engineering studies for new processes and to improve existing processes. Develop and implement SOPs and batch records in support of new and upgraded processes. Conduct effective training of manufacturing personnel related to technical transfer and new and upgraded processes. Represent manufacturing on process design teams. Support Validation to execute commissioning, process validation and cleaning validation protocols for processes and equipment. Champion projects as they move into and through the manufacturing areas. Provide regular updates to manufacturing management on the status and issues involved in projects. Actively support on-going manufacturing efforts in terms of quality and efficiency. Conduct troubleshooting of issues and non-conformance items and initiate plan of action. Monitor Process Parameters. Support investigations with trending and data analysis. Initiate Change Controls and perform/coordinate required actions for completion. Support manufacturing management in periodic review of existing and new revisions to manufacturing documentation.

Subject matter expert on bulk microsphere, and polymer manufacturing. Provide major support in suspension manufacturing as well as powder and liquid filling. Responsible for monitoring process parameters through data trending and statistical analysis of multiple processes. Manufacturing liaison in project planning and coordination. Optimize current processes to improve efficiency, quality and process robustness. Provide technical depth and support for investigations. Work with process teams to design, build and startup process systems including piping, instrumentation, controls and equipment systems. Write engineering studies, technical reports, change controls, equipment specifications and SOPs. Support Validation to execute commissioning, process validation and cleaning validation protocols for processes and equipment. Conduct effective training of manufacturing personnel related to technical transfer and new and upgraded processes. Champion projects to continuously improve processes using project management and Six Sigma techniques. Conduct troubleshooting of issues with manufacturing processes including equipment, PLC systems and non-conformance items and initiate corrective action plan. Provide support for the repair, preventive maintenance and spare parts programs.

Provide interface with Development and Engineering in technology transfer of new processes as well as process upgrades to existing technologies. Act as manufacturing liaison in project planning and coordination. Design and execute engineering studies for new processes and to improve existing processes. Develop and implement SOPs and batch records in support of new and upgraded processes. Conduct effective training of manufacturing personnel related to technical transfer and new and upgraded processes. Represent manufacturing on process design teams. Support Validation to execute commissioning, process validation and cleaning validation protocols for processes and equipment. Champion projects as they move into and through the manufacturing areas. Provide regular updates to manufacturing management on the status and issues involved in projects. Actively support on-going manufacturing efforts in terms of quality and efficiency. Conduct troubleshooting of issues and non-conformance items and initiate plan of action. Monitor Process Parameters. Support investigations with trending and data analysis. Initiate Change Controls and perform/coordinate required actions for completion. Support manufacturing management in periodic review of existing and new revisions to manufacturing documentation.

Major role in planning, organizing and analyzing daily work assignments. Assist with initiating and completing PRs and change controls. Review CIP, SIP and batch mfg reports. Key Operator and communication liaison for other departments in support of various projects, experiments, studies and activities associated with bulk formulation line. Support Team Leader with assistance where needed.Perform development and production activities for bulk formulation line. Review/update SOP’s and batch records. Author new SOP’s and protocols. Lead troubleshooting and process improvement activities including corresponding documentation. Review completed production documentation (batch records, log books, etc.) for quality and cGMP compliance. Initiate appropriate action when process deviations occur. Responsible for the documentation and tracking of employee training and performing OJT for new operators. Support validation/development/engineering and tech transfer activities.

Perform development and production activities for bulk formulation line. Review/update SOP’s and batch records. Author new SOP’s and protocols. Lead troubleshooting and process improvement activities including corresponding documentation. Review completed production documentation (batch records, log books, etc.) for quality and cGMP compliance. Initiate appropriate action when process deviations occur. Responsible for the documentation and tracking of employee training and performing OJT for new operators. Support validation/development/engineering and tech transfer activities.

Responsible for the inspection, sampling, and release of all incoming controlled materials. Lead Materials Release Priority meetings for the coordination and tracking of all controlled materials in order to meet crucial timelines. Perform and compile critical material investigations. Review and approve environmental monitoring records, system/equipment/instrument logbooks, batch records, and numerous other controlled documents per FDA guidelines and requirements. Engineer installation and operation qualifications for various equipment and instrumentation. Perform AQL (assurance quality level) inspections on filled vials for shipment approval. Execute audits of clinical labeling operations at outsourced companies. Facilitate training of new and temporary employees as needed.

Provide secretarial support to General Manager and management team. Interface with a wide variety of outside business contacts. Host visitors. Schedule travel. Execute general administrative tasks and perform special projects for Financial, Business Development, and Human Resources. Manage the administrative affairs of the office.