* Ensure plant readiness

* Manage the overall relationship with internal / external manufactures and act as the single point of contact between the organization and the respective manufacturing site

* Provide pilot plant input & requirements to Drug Product Development (DPD) / Primary Container Development (PCD)

* Support scale-up and Tech-Transfer

* Put relevant manufacturing information and technical capabilities in place for the operations team to flawlessly produce the DP according to GxP, EHS and business requirements

* Supports investigations, CAPAs, change controls according to assigned responsibilities and performs critical raw data review for key documents

* Assess new technologies / applications: feasibility, business case, conceptual design, installation and implementation

* Prepare business plan forecasts and monitor actual spend vs budget.