Responsibilities: Provide statistical programming support to generate SDTM and ADaM datasets, tables, listings, and figures for individual studies and ISS/Client to FDA, EMA, and other worldwide regulatory agencies. Participate in the re...
Responsibilities: Previous experience in inhalation drug delivery. Has broad knowledge of medical device development, design controls and risk management. Led and managed development of DHF (design history file) deliverables for medical...
Responsibilities: Provide quality oversight for drug product process technology transfers, including development and engineering activities to be leveraged. Provide quality oversight for drug product process qualification/validation prot...
Responsibilities: Participate in Core Supplier Management teams for purchase orders, together with the Sourcing/Fulfilment and Engineering representatives. Work with procurement teams to define / agree / communicate to all stakeholders a...
Responsibilities: Responsible for performing basic and intermediate OptiBuild production process, both manual and automated, according to established procedures and work instructions. Responsible for managing their material inventories, ...
Responsibilities: All Custom Reagent Technician I responsibilities. Basic set up and assembly procedures. Intermediate Custom Order processing. Material inventory management and accountability. Working within the SAP production system...
Responsibilities: Develop, optimize, and validate analytical methods for protein-based biologics. Conduct separation techniques, including HPLC (SEC, IEX, HIC) and capillary electrophoresis. Perform routine laboratory tasks such as samp...
Responsibilities: Provide training and collaborate with the transitioning employee to ensure knowledge transfer. Support the implementation of the Process Operations Management System (POMS) and Electronic Batch Records (EBR). Focus on ...
Responsibilities: Quality Engineering is responsible for product and service quality evaluation and control. Works cross-functionally in the development and or maintenance of products or services. The Engineer is involved in resolving t...
Responsibilities: Lead/contribute to device development, design controls and risk management strategy for the assigned projects. Lead the implementation and/or ensure effective execution of the device development strategy, design control...