IDT Biologika is a leading global CDMO focused on viral vaccines, viral vectors, and other biologics, with end –to-end development and manufacturing capabilities in Germany and the US. IDT works with external partners (Outsourced Testing Labs or OTLs) to complete quality release testing on select assays such as mycoplasma, adventitious virus etc. The role is accountable for end to end management of testing performed at OTLs to ensure active management of the relationship with IDT’s OTL partners, ensure on-time delivery of results, drive technical discussions to resolve any issues, and driving continuous improvements to the relevant business processes.

The role consists of two aspects:

Input into new business proposals: Accountability to keep an accurate record of testing capability of current OTL partners, current pricing, technical pre-requisites, capabilities and risk. Provide input on the best OTL partner for a given program based on technical capabilities, timeline, cost, and other relevant factors.

Management of contracted OTL Testing: Accountability to manage ongoing testing, including reviewing quotes, coordinating sample shipments (domestic and international) ensuring required permits are in place, and reviewing test results to ensure it meets the regulatory requirements. Maintaining detailed sample shipment, testing schedules, and communicating/presenting to the internal and external stakeholders.

Proactively identifying potential technical or logistical issues and interfacing with OTL and internal stakeholders as required to address to ensure on time delivery. The incumbent will also be responsible for building and driving continuous improvements to the business processes in QC for both OTL and internal testing as required.