Responsibilities: The Genomic Medicine Unit Chemistry Manufacturing & Control (CMC) development organization is responsible for all aspects of drug development, from molecule/pre-candidate to product approval. This encompasses drug subst...
Responsibilities: Independently perform validation activities including installation qualification, operational qualification, performance qualification for Base Camp projects related to facility, utilities, equipment and instrument. Gen...
Responsibilities: Local Validation Program Maintenance. QAV Documentation Review and Approvals for local and CMO's. CS Periodic Reviews planning and approvals. QA GMP IT Support for DI and CS INF activities. Validation and Metrology Q...
Responsibilities: The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA submission and oversee and manage all ANDA regulatory activities pre- and post- submission. This role is critical in ens...
Responsibilities: Primary coding resource for assigned products and studies. Accurately codes assigned data fields including, but not limit ed to, adverse events using MedDRA and concomitant medications using WHO Drug in accordance with ...
Responsibilities: Assists in optimization of current processes, and development of new processes in support of R&D, Manufacturing and Product Development. Provides support and guidance on validation activities related to manufacturing/te...