Clinical And Commercial Process Development Bardi

Clinical And Commercial Process Development
Bardi
Emilia Romagna, Bardi

You will join a newly-built and state of the art Pharmaceutical Development unit, and as a part of our pilot scale manufacturing department, you will support our Clients in developing new manufacturing processes and technology transfer for small scale/clinical trial sterile production. In this role you will lead clients projects from a technical standpoint, developing the optimal manufacturing process, defining the equipment needed, and configuring manufacturing equipment to meet production requirements. A hands-on, goal-driven attitude will be key in exceeding clients expectations, and the ability to think out of the box, coupled with a strong technical experience, will help you in troubleshooting and finding new solutions to problems. Responsibilities As the technical owner of the project, defines the materials to be used during the manufacturing of liquid and lyophilized products and decides the manufacturing process flow. Act as the main point of contact with internal and external stakeholders, managing the approval process. Prepare the technicaldocumentation required by internal SOP such as Master Batch RecordParticipate to clinical/commercial batches manufacturing inside PDS sterile suite. Update the clients about the state of the project, proactively anticipating issue and ensure a timely management of technical problemsRequired Skills and ExperienceDegree in Chemistry/ CTF/ Biological Sciences or similar fieldsAt least 2 years of experience in pharmaceutical R&D, in engineering, manufacturing or quality units with liquid and lyophilized sterile injectablesExperience with drugs formulation and aseptic manufacturing processExperience in drafting GMP documentation such as MRBs (Master Batch Record)Strong communication and team-working skillsAbility to organize and manage multiple projects and activities in a highly dynamic environmentFluent English and ItalianThis role offers the opportunity to grow as a technical leader of R&D manufacturing processes with state-of-the-art equipment and, as a client facing role, the chance to directly interact with pharmaceutical companies from all over the world and enhance your communication and project management skills.