Executive/ Sr. Executive- Technology Transfer

Role & responsibilities

• Responsible for the technology transfer of in-house developed formulation manufacturing processes from R&D to the manufacturing site
• Responsible for successful execution of CDMO & CMO manufacturing operations.
• Support commercial/launch PV batches to ensure right first time process implementations
• Acts as liaison between R&D and manufacturing site, including regular on-site representation of R&D at the manufacturing site during technology transfer and process validation batches.
• Manage and execute the operational project activities related to the technology transfer and GMP production.
• Plan the technology transfer by using appropriate tools such as gap analysis, risk assessment and/or technology transfer protocol.
• Lead technical meetings and coordinate execution of project deliverables related to tech transfer including scale up, PV and registration batches with assistance of the formulation development team.
• Oversee adherence of technology transfer activities to program timelines and budget.
• Report on the progress of technology transfer tasks to relevant stakeholders and management.
• Control data and material exchange between R&D and manufacturing site as well as from external vendors.
• Train development staff in best-practices to develop GMP compliant processes.
• Need eye for detail, excellent capability to plan and execute tech transfer activities in the plant.
• Support process optimization, scale-up, provide technical support for manufacturing and troubleshooting of commercial products
• Enable regular project tracking by communication with related departments like project management, business development, analytical department, RA, IPR, QA, QC, Store, Purchase, manufacturing site.
• Preparation and review of relevant documents (MFR, BMR, TTD, PDR). Preparation of relevant SOPs & implementation.
• Sound knowledge of use of PAT Tools in product development/pilot/commercial or launch batches
• Support evaluation of machinery vendors and FAT and trial runs for new equipment, change parts for existing machinery and punch tools
• Evaluation of project feasibility in terms of technical, commercial and costing considerations in coordination with cross functional departments
• Well versed with Microsoft Office tools, DOE software
• Calculate and propose pilot/registration/PV batch sizes based on annual forecast and current equipment capacities as well as batch costing.
• Review Process performance qualification reports of commercial/launch batches

Preferred candidate profile

The role is to be the technically competent connection between R&D and plant sites and align with organizational goals & objectives. The job requires a good knowledge of oral solids, liquids and injectables manufacturing processes. Additionally, pro-active cooperation and clear communication with colleagues & stakeholders within and outside the company (where applicable) is essential.