Here, in Nivelles (Belgium), you will join a collaborative team full of passionate change-makers.
The Vaccine Technical Development team has the ambition to position Univercells Vaccines 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. The Vaccine Technical Development department is in charge of the Drug Substance production process development, performed within Univercells Vaccines facilities and of the Drug Product production process development managed through external collaborations.
The Drug Product Expert works within the Vaccines Technical Development department and thanks to her/his expertise is responsible for leading the activities, related to the development of drug product for vaccine production processes, that are carried out by Univercells Vaccines in collaboration with external partners. In compliance with corporate values, the Drug Product Expert collaborates with the Vaccines Deputy CSO & CTO, the external partners and the Drug Substance development teams to ensure the development and the validation of Drug Product production processes in such a way that they are made effective and fully compatible with vaccine production process.
- He/she manages Drug Product projects and collaborates with external partners to ensure robust processes development with the best technical solutions to commercial vaccine product manufacture, with minimum complexity, cost of goods and meeting the agreed Quality Target Product Profile.
- She/he gets involved in the conception, design, implementation, and interpretation of scientific and technical data to support projects.
- She/he writes and reviews reports in support of various project.
- She/he makes sound scientific / technical and business decisions based on a balance of data, analysis and experience.
- She/he solves complex problems through collaborations with others, taking a new perspective on existing solutions
- She/he provides state-of-the-art product and process expertise to support the Vaccines Deputy CSO & CTO, external partners, Univercells’ MSAT and Life Cycle Management team. He/she establishes and maintains strong collaboration and interaction both locally and globally with internal and external partners and contribute to project plans for delivering the expected product and process innovations and knowledge.
- The Drug Product Expert manages Technology Transfer of Drug Product production processes from sending units (external partners) to the receiving units (Univercells or other external partners). She/he leads and manages interactions between teams to create the required documentation (Tech Transfer plan, Tech Transfer report, …) by respecting internal quality system.
- The Drug Product is responsible for ensuring the proper execution of Process Validation activities by the external partners or by Univercells units.
- Writing and management of documentation related to the Drug Product process development and project management.
- 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
- MSc or PhD degree in Science, Pharmacy, Biochemistry or equivalent life sciences degree with at least 5 years experience in pharmaceutical industry and in Drug Product development, preferably in vaccine formulation and drug delivery systems development
- Proven scientific knowledge of Vaccines manufacturing and analytical testing.
- Full understanding of compliance and cGMP considerations
- Strong leadership combined with organizational planning and project management skills
- 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).