Position: Quality Assurance Manager at ADVENT ADVENT is a GMP-certified Contract Development and Manufacturing Organization,…
Job Position: Production associate, Downstream unit.
IRBM Group has a GMP-certified Contract Development and Manufacturing Organization, ADVENT, 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-Downstream unit, in Advent. She/he will join a fast-paced team and will support the overall GMP manufacturing process with particular emphasis on the downstream process. The 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.
- Perform process development studies for viral products. Under moderate/minimal supervision, set-up and optimize downstream process steps, including but not limited to:
- Depth filtration;
- Virus purification through tangential flow filtration and AKTA chromatography systems;
- Process buffer/Formulation buffer preparation.
- Under moderate/minimal supervision, perform GMP activities like:
- Production of small-scale clinical lots, including but not limited to, bulk DS (drug substance) generation and purification;
- Monitoring of clean room environment;
- Adherence to current GMP by following Standard Operating Procedures and by executing Batch Production records using good documentation practices;
- Report any unexpected observations and suggest possible explanation and resolution;
- Work cross-functionally with the team.
- Maintain high standards of laboratory safety, comply with all safety requirements according to Italian laws.
- Good communication skills, both verbal and written. Working knowledge of spoken and written English.
- Outstanding organizational, record-keeping, and problem-solving skills.
- Proven experience in standard molecular and cell biology procedures, including tissue culture, protein and nucleic acid manipulation, experimental planning and data interpretation.
- Proven experience in protein purification, expertise in AKTA platform.
- Ability to work well independently and/or in a team to meet tight timelines.
- Working knowledge of computer programs such as MS Office, Adobe Acrobat, Unicorn platform.
- Knowledge of current GMP principles and previous experience in bioprocessing would be considered a plus.
Master Degree in Biochemistry or related fields with at least 3-4+ years of relevant research experience
Previous experience in Biotech or Big-Pharma environment would be considered a plus.