This position designs, implements and maintains programs, policies, and practices to ensure that the activities of the Facilities and Engineering (F&E) Department are in compliance with GMP-requirements.
To provide process engineering /maintenance support to the Manufacturing Facility and develop/establish the maintenance/engineering tools/programs to ensure that the facility is kept in a good state of repairs as well as all process equipment and that we are cGMP compliant from a facility, maintenance and engineering perspective.
Supports Laboratory master data by means of designing and maintaining test methods, specifications, sampling plans etc. to support laboratory and manufacturing operations while ensuring accuracy and compliance to regulations.
Oversee the day-to-day operation of a study or series of studies within one or more clinical development programs; interface with Directors to provide tactical/operational leadership to members of the study team.
Serve as primary authors, reviewers, and approvers of regulated documents such as method validation/qualification protocols, reports, transfers, SOPs, change controls, investigational reports, and deviations.
Provide signatory approval for supplements and amendments to INDs/BLAs, assuring submissions are completed within specified regulatory timeframes; review and approve all materials to be included in submissions for accuracy and completeness, which include stability, validation and investigations.