He/She will be the responsible for the upstream 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 upstream phase production team and will proactively collaborate with his/her supervisors providing 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 cell production process, suggesting the proper solution for the process improvement (including yield optimization and control of manufacturing related costs).
- Identify and suggest the proper technologies to implement the upstream production phase in ADIENNE’s facility.
- Develop the optimal cell growth conditions related to new production processes.
- Run the upstream phase process scale-up and the manufacturing of validation batches.
- Execute the In Process Control (IPC) during the manufacturing activities related to the upstream Phase.
- Work in accordance to the cGMP and the internal quality system.
- Prepare the budget of the upstream process.
- Verify project timeline and costs.
- Supervise the activities of the upstream team and verify the continuous updating of personnel about technical state of the art.
- Degree or Ph.D. in biotechnology, biology or related discipline with strong laboratory skills and at least 3 years’ experience in an industrial environment.
- Practical experience with common USP equipment (shake flasks, cell retention devices e.g. Ambr, single use bioreactors from 10L to 1000L, perfusion bioreactors).
- 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.