Key Responsibilities include:
* Ensure timely plant readiness to support experimental / clinical activities
* Ensure timely delivery of clinical material from internal pilot plants or from external contract manufacturing organizations (CMO)
* 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
* Source raw materials and components as required. Point of contact for material and supplier related issues at CMO.
* 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.