CAREERS
CAREERS
Position:
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.
Job Description:
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.
Key responsibilities:
A. Process development and scale-up of viral products (adenovirus, AAV) under moderate/minimal supervision:
- Routinary laboratory activities focused on purification and filtration of macromolecules (proteins and nucleic acids) by depth filtration, tangential flow filtration, chromatography.
- Production of small-scale lots (20-50L) in a R&D environment.
- Standard laboratory analysis for biochemical/biophysical characterization of macromolecules (e.g. SDS-PAGE, spectroscopy).
- Design, troubleshooting and optimization of downstream process steps. Literature research, experiment planning, record of activities, experimental data analysis, presentation of project updates.
- Set-up and maintenance of area operations and equipment, lab inventory maintenance.
- Maintain high standards of laboratory safety, comply with all safety requirements according to Italian laws.
B. cGMP manufacturing of clinical batches and auxiliary GMP activities, with minimal supervision:
- Routinary activities in a cGMP manufacturing plant, executing QA approved Batch Manufacturing Records (BMRs) as Operator/Verifier for: preparation of buffer solutions, generation and purification of bulk DS (Drug Substance), aseptic filling of DP (Drug Product).
- Adherence to cGMP by following Standard Operating Procedures (SOPs).
- Draft of Batch Manufacturing Records (BMRs), Protocols and SOPs.
- Environmental monitoring (viable and non-viable particles) of classified areas, preparation of materials for autoclave sterilization, product inventory maintenance, performance verification/calibration of equipment, training, material sampling.
Basic Experience/Skills:
- Master Degree in Biochemistry, Structural Biology or related fields with a minimum of 3 years of relevant research experience in a laboratory. In alternative, a minimum of 3 years of experience with viral vector production in mammalian cells is required.
- Hands-on expertise in chromatography using AKTA systems (Unicorn software) is mandatory.
- Good communication skills, both verbal and written. Working knowledge of spoken and written English is mandatory.
- Outstanding organizational, record-keeping, and problem-solving skills. Ability to work well independently and/or in a team to meet tight timelines.
- Attention to detail in execution of written protocols.
- Working knowledge of computer programs such as MS Office, Adobe Acrobat, Unicorn platform.
Additional Requirements:
- Hands-on experience on AAV or adenovirus systems will be considered a plus.
- Hands-on experience with HPLC systems would be considered a plus.
- Previous experience in Biotech or Big-Pharma environment would be considered a plus.
- Knowledge of current GMP principles and previous experience in bioprocessing would be considered a plus.