He/She will be the responsible for the downstream phase of any Biologics production implemented in ADIENNE, including monoclonal antibodies, vaccines and ADC programs.
Operating under the direction of the ADIENNE Pharma & Biotech Chief Scientifc Officer and ADIENNE Srl SU Head of Biotech Operations He/She will be the leader of the downstream phase production team and will proactively collaborate with his/her supervisorsproviding a technical evaluation of any new product or process in order to achieve the commercial target defined by ADIENNE.
He/she will interact with the QC department for analytical methods definition and development and he/she will also write and review Standard Operating Procedures (SOPs) for his/her area of responsibility or any other technical documentation required by ADIENNE.
- Investigate all the critical aspect of the downstream process, suggesting the proper solution for the process improvement (including yield optimization and control of manufacturing related costs).
- Participate in the identification of the proper downstream technology to apply in the new production process that will be implemented in ADIENNE.
- Develop the optimal purification solutions (ultrafiltration, diafiltration, preparative purification, etc.) related to new biologics production processes.
- Run the downstream phase process scale-up and the manufacturing of validation batches.
- Execute the In Process Control (IPC) during the manufacturing activities related to the downstream phase.
- Work in accordance to the cGMP and the internal quality system.
- Prepare the budget of the downstream process.
- Verify project timeline and costs.
- Supervise the activities of the downstream team and verify the continuous updating of the downstream team
- Degree or Ph.D. in biotechnology, biology or related discipline with strong laboratory skills and at least 3 years’ experience in an industrial environment.
- Experience in purification using automated systems (ÄKTA) and membrane ultrafiltration (TFF), and analytical characterization techniques such as column chromatography (HIC, SEC, IEX), UV-Vis spectrophotometry, microfluidics (CE-SDS, iCEF) and LC-MS.
- Experience in the application of Design of Experiment principles and PAT for in process control and release.
- Resilient with the ability to manage multiple and varied task and prioritize workload with a strong attention to details.
- Ability to engage constructively with colleagues at all levels of the organization to deliver objectives.
- High degree of motivation with the ability to apply critical thinking to data and process, with a solution-oriented prospective.