Head of Process Development

Job Description

**THE COMPANY**

Pharmaceutical Multinational Company

**HEAD OF PROCESS DEVELOPMENT**

**THE ROLE**
- Proposes a suitable organization and the hiring of appropriate personnel (employees and/or consultants) to perform Process Development and Tech Transfer activities and new CDMO business-related development projects as agreed in time and with appropriate documentation.
- Owns and actively manages the overall process development schedule to ensure that personnel and equipment resources are utilized as efficiently as possible and project-related timelines are respected.
- Liaise with the Analytical Development organization in other plant in UK to ensure a smooth and effective exchange of project-related technical information.
- Coordinates Tech-Transfer and general communication between other plants in UK, as well as other internal and external clients.
- Continuously evaluates and optimizes the organization (personnel and workflows) to support current project needs and objectives (i.e. new projects, changed priorities).
- Manages and controls the PD budget (CapEx & OpEx).
- Proposes an appropriate yearly budget based on the projected activities/projects and agreed internal development programs.
- Communicates deviations to Top Management.
- Liaise with Business Development supporting BD in technical discussions with potential clients.
- Active participation in congresses and other scientific events delivering scientific presentations, thus increasing the visibility as a CDMO in the market.
- Ensures that all technical equipment is installed and maintained according to the supplier’s specifications and is qualified and serviced according to GLP requirements and manufacturer specifications.
- Communicates to and supports all team members to utilize the equipment (process development equipment) available in the most effective way
- Defines a project structure supporting the preparation and execution of Tech Transfers between other plants in UK, Italian Manufacturing, and potential external clients in close cooperation and alignment with the responsible project manager.
- Provides scientific, regulatory, and technical support during the Tech Transfer phase and during the implementation of processes and analytical methods.
- Ensures that project deliverables (i.e. data, product, documentation) are generated and shared according to the overall project plan.
- Provides scientific leadership and knowledge for process development activities including but not limited to cell line development, upstream development, downstream development, and formulation development.
- Ensures that all technical equipment is installed and maintained according to the supplier’s specifications and is qualified and serviced according to GLP requirements and manufacturer specifications.
- Communicates and supports all team members to utilize the equipment (process development equipment) available in the most effective way

**JOB REQUIREMENTS**
- PhD or master’s degree in Biotechnology, Biochemical Engineering, Biology, with a number of years of relevant experience in industrial Biopharmaceutical Process Development and/or Manufacturing.
- Proven experience leading an Upstream or Downstream Process Development group, or leading the entire Process Development group.
- Proven experience in leading and guiding Biopharmaceutical Process Development teams (people manager), taking responsibility and making risk-based decisions.
- Ability to work in a very dynamic environment with tight timelines, being able to shift priorities as required.
- Excellent communication skills paired with a service-oriented mindset.
- Advanced language skills in Italian and excellent language skills in English are mandatory.
- Demonstrated hands-on Upstream
- and Downstream process development experience with recombinant proteins or antibodies derived from CHO cell culture systems.
- Able to work productively in a highly collaborative, team-oriented environment striving for improvement of process technologies and process development efficiency.
- Excellent attention to detail as well as communication and organization skills.
- Previous experience managing projects in a highly matrixed environment is important

**LOCATION: Roma Sud**

**Ref: Head of Process Development