Position: Production Associate (Process Development) at IRBM
IRBM Group has a GMP-certified Contract Manufacturing Organization, 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 upstream 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 upstream process steps, including but not limited to:
- Culturing of mammalian cell cultures (adherent and suspension) at different scale, also by the use of disposable bioreactors;
- Growth media formulation and process buffer preparation;
- Cell Train Amplification method authoring and editing applied to cell bioreactors;
- Depth filtration.
- Under moderate/minimal supervision, perform GMP activities like:
- GMP production of adherent or suspension Master Cell Banks (MCB);
- Production of small-scale clinical lots, including but not limited to, MCB propagation, MVS (master virus seed) and bulk DS (drug substance) generation;
- Constant monitoring of clean room environment;
- Adhere to GMP’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.
- 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.
- 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, Vector NTI, Prism.
- Knowledge of cGMP principles and previous experience in bioprocessing would be considered a plus
- Bachelor’s degree in Biology, Biochemistry, Molecular Biology, Cell Biology or related field
- Experience in relevant positions in Biotech or Big-Pharma environment would be considered a plus.