Production associate, Downstream unit at Advaxia Biologics
IRBM Group has a GMP-certified Contract Development and Manufacturing Organization, ADVAXIA, located in Pomezia (Rome) within the IRBM campus and dedicated to production of clinical lots of recombinant adenovirus to support Phase I and Phase II clinical trials for vaccine and gene therapy applications. Our GMP is authorized to produce investigational medicinal products by the Italian National Regulatory Authority (AIFA) and is compliant with the regulatory guidelines of both FDA and EMA. Over the years, the GMP team has built an outstanding track record in the successful production of clinical lots and is committed to the highest GMP quality standard.
We are looking for a highly motivated and team-oriented candidate for the position of Production Associate in our organization. She/he will join a fast-paced team and will support the overall GMP manufacturing process with particular emphasis on the downstream process. In this site-based position, the successful candidate will work cooperatively in cross-functional teams to ensure that manufactured materials meet required specifications and regulatory requirements. As an IRBM employee, she/he will be committed to the highest operational standard and will contribute to the timely delivery of our services and products to our customers and their patients. A collaborative attitude is essential for this position. Shift work and/or weekend work will be required at times.
A. Process development and scale-up of viral products (adenovirus, AAV) under moderate/minimal supervision:
B. cGMP manufacturing of clinical batches and auxiliary GMP activities, with minimal supervision: