Responsible for technical activities for the commercial manufacturing process at the CMO Partner, which includes authorship of change control, management of process improvement projects, and analysis of process performance.
Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
Provide on-site coverage at External Partner in support of Commercial and / or Technology Transfer Person-In-Plant Activities.
Translate understanding of GMP requirements and current regulations and develop standardised work to meet these requirements by partnering with Operations, Quality, and External Partners.
Ensure that External Partners are inspection ready for all routine inspections and / or inspections related to new product introduc...