At Univercells, we are on a mission to make health equally accessible to all. We work every day to reinvent biomanufacturing processes, and develop or integrate the next innovative technologies. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: Biologics available and affordable to all!! This job is the perfect opportunity to contribute to our mission and be impactful.
Based in Nivelles and Gosselies, the Vaccine Process Development team has the ambition to position Univercells as a key player and a reference in the development of new technologies for vaccine production by proposing solutions breaking the barriers to bioproduction and making vaccines available and affordable to all.
Thanks to her/his expertise, the Vaccines Industrialization Expert is carrying out the activities related to the industrialization of vaccine production processes in Univercells Vaccines in compliance with corporate values.She/he works in collaboration with the Vaccines Development teams to ensure that the final development and scale-up of the upstream and downstream processes are carried out in such a way that they are made effective and fully compatible with commercial production.
The Industrialization expert is responsible for ensuring the proper implementation of Process Characterization activities in the Technical Development department by leading the activities or by supporting the managers.
The Industrialization Expert is responsible for the Technology Transfer of vaccines processes from sending units to the receiving units when the sending unit is the development plan. She/he leads and manage interactions between teams to create the required documentation (Tech Transfer plan, Tech Transfer report, …) by respecting internal quality system.
Process development & scale up
Work in collaboration with the Vaccines technical development team on the design of the final process and on the scaling-up to the final process by taking into account the manufacturing constraints
Ensuring the proper implementation of Process Characterization activities in the Technical Development department :
- Identify the CQA, the CMA and the CPP with the Development team.
- Works in collaboration with Vaccines Development teams to perform the Process design and process characterization.
- Works in collaboration with Vaccines Development teams and QC to establishment of the Controls Strategy and ensure analytical method validation.
- Support the Manufacturing unit to generate the Process Validation Master Plan.
- Support the Manufacturing unit for Process Qualification (Engineering run, validations and PPQ campaign).
- Support the Manufacturing unit for the establishment of Continuous Process Verification plan and for its implementation
- Carry out the Technology Transfer of vaccines processes from Vaccine Technical Development teams (Upstream, Downstrean, Analytical) to the Pilot Plant
- Support the Technology Transfer of vaccines processes from the Pilot Plant to the Commercial production unit.
- Ensure the Technology Transfer of analytical methods from Analytical development team to QC unit.
- Carry out the Technology Transfer by involving RA, QA, QC, Project Management, Facilities and Procurement departments.
- Lead and manage interactions between teams to create the required documentation (Tech Transfer plan, Tech Transfer report, …) by respecting internal quality system
- Writing and management of documentation related to the Technology Transfer and Process Characterization : plans, reports
Quality, Safety & continuous improvement
- Adherence to standard operating procedures and guidance in all described activities.
- Correct use and implementation of quality management system within the field of activities.
- Identification and reporting of deviations from standard operating procedures and of unexpected events through initiation of related investigations.
- Support of corrective and preventive actions related to deviations and unexpected events.
- Generation of process quality documentation for vaccines platform (procedures, work instructions, templates, etc.).
REQUIREMENTS / QUALIFICATIONS
- Master Degree with a minimum of 3 years experience in industry
- Minimum 3 years of experience in Vaccine production processes, Technology Transfer and Process Characterization/Validation..
- Full understanding of compliance and cGMP considerations
- Excellent communicator with the ability to transfer knowledge and give confidence to customers
- Driven by curiosity and eager to learn more every day. With a strong desire to be impactful.
- Self-motivation and interest in fast-growing companies/SMEs.
- Integrity and transparency.
- Strong sense of observation, inventive & critical mindset, scientific curiosity and problem-solving skills.
- Proactivity, flexibility, work organizational skills
- Enthusiasm and agility to work on a variety of projects.
- Capability to leverage know-how in order to participate in the development of the new generation solutions.
- Capability to work in a cross-functional and multi-cultural team.
- Fluent in English (written and spoken).