The Process Development Expert main role is to develop or optimize production process steps associated to one project and to transfer the process in GMP cleanrooms.
The Process Development Expert works in a small manufacturing team on the production of several extracellular vesicle based therapeutic products in a GMP environment under the supervision of the Production Manager. The position requires professional interaction with clients, suppliers, service providers and close collaboration with other departments (QA, QC, supply chain, …).
In order to fulfill his/her role, the Process Development Expert:
· Is involved in technology transfer from the client, including meetings and observation of production at the customer’s premises.
· Is involved in the project follow-up as regards the development phase of the project including contact with the clients, results reporting and presentation.
· Supervises and performs cell culture in technology transfer lab according to current procedures and reports progress and issues to the Production Manager and to the Project Manager.
· Keeps up to date with scientific literature, and new technologies related to the project.
· Suggests new approaches and brings ideas to be discussed internally before communication with the client.
· Independently designs process characterization studies aimed at reducing batch-to-batch variability, optimizing and improving production yield, establishing process parameters and critical quality attributes.
· Assists in determining manufacturability of candidate products.
· Draft protocols, batch records and development reports.
· Is responsible for the transfer of the developed process steps to GMP clean rooms, in due time according to the project plan.
· Is responsible for ordering adequate material and its availability in due time.
· Documents his/her work according to current procedures, and GMP when required.
The Process development expert supports GMP production when needed:
· Execute manufacturing processes of extracellular vesicle based pharmaceutical products in a cleanroom environment in accordance with the cGMP guidelines and regulations.
· Contemporaneously document manufacturing activities and observations in the applicable records.
· Report deviations from the established standard operating procedures, perform root cause investigation and implement corrective and preventive actions.
· Generate and revise manufacturing procedures (batch records, SOP’s, protocols, reports, …)
· Perform facility and equipment maintenance and cleaning.
· Acquires proficiency in utilizing the EMS alarm system and be a key contact in the call list for clean room emergencies.
· Performs aseptic processes in a grade B cleanroom (tissue processing, cell culture, final filling …)
· Installs, operates and monitors closed system processes in a grade C cleanroom environment.
· Participates in aseptic process simulation activities.
· Assists in qualifying the clean rooms and performs environmental monitoring.
· Is willing to work flexible hours when required for scheduled process activities.
· Schedules and plans their office time to create new GMP documents and/or revise existing ones according to the agreed timelines.
· Ensures the on-time delivery of all batch related records and documents to support the batch release process.
· Warns immediately the Production Manager in case of problem or failure.
· Double checks data generated by other operators.
· At least Bioengineering degree or master’s degree in chemistry, biochemistry, biology, pharmacy, etc.
· At least two years’ experience in in mammalian cell culture
· At least one year experience in a process development or MSAT function
· Experience working in a GMP environment and writing procedures is required.
· Customer oriented
· Good communicator, cheerful
· Teamwork and teaching skills
· Pragmatic, solution driven mindset.
· Responsible working attitude, Proactive and autonomous
· Quality minded, autonomous, rigorous, attentive to details, persevering and pro-active
· Maintains open, effective, constructive and positive communication with colleagues in the team and in other departments.
· English at least B2
Do you want to join us?
Please get in touch with our HR-manager via email@example.com
EXO Biologics mission is to provide affordable and accessible exosomes therapy to patients with unmet medical needs.