Position: Quality Assurance Manager at ADVENT ADVENT is a GMP-certified Contract Development and Manufacturing Organization,…
Job Position: Production Associate ADVENT, IRBM.
IRBM Group has a GMP-certified Contract Development and Manufacturing Organization, ADVENT, located in Pomezia (Rome) within the IRBM campus and dedicated to the 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 upstream process. In this laboratory-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.
Under moderate supervision, perform daily production activities under cGMPs like:
- Production of small-scale clinical lots, including but not limited to, MVB (Master Viral Bank), bulk DS (Drug Substance) generation and DP (Drug Product) filling;
- Production of small-scale toxicology lots, including but not limited to, MVB (Master Viral Bank), bulk DS (Drug Substance) generation and DP (Drug Product) filling;
- Constant monitoring of clean room environment;
- Adhere to cGMP’s by following Standard Operating Procedures and executing Batch Production records using good documentation practices;
- Report any unexpected observations and suggest possible explanation and resolution.
- Work cross functional with the team to provide resources as needed.
Under moderate supervision, perform process development activities in R&D environment like:
- Perform/participate in process development studies for viral products including Engineering run/Feasibility studies
- Cell thawing, amplification and freezing (adherent and suspension mammalian cells)
- Use of Cell Bioreactors and Single Use bioreactors
- Virus construction, isolation and characterization
- Cells infection (i.e. adenoviral platform), including setting of infection conditions (e.g.: cell concentration, MOI, time of harvest)
- Maintain high standards of laboratory safety and comply with all safety requirements according to Italian laws.
- Good communication skills, both verbal and written.
- Fast response to support operational and documentation customer requests in a proactive manner
- 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.
- Ability to work well independently and/or in a team to meet tight timelines.
- Working knowledge of spoken and written English is mandatory
- Working knowledge of computer programs such as MS Office, Adobe Acrobat
- Knowledge of cGMP principles and previous experience in bioprocessing would be considered a plus
- Master Degree in Biology 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.
- Proven experience in use of Cell bioreactors and SU Bioreactors would be considered a plus