Exothera, one of Univercells’ subsidiaries, is the newly launched contract development and manufacturing organization (CDMO) that supports cell and gene therapy developers with process development and production of viral vectors.
Exothera is uniquely positioned to create bespoke bioproduction support programs for manufacturers to achieve successful market entry.
At Exothera and 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 state of the art process development, analytics, and engineering expertise, we create synergies to deliver game-changing production capacities.
This job is the perfect opportunity to contribute to our mission and be impactful.
Supervising one of the operational groups in the Development unit of Exothera at Gosselies, the Analytical Science Manager will be responsible for the scientific and operational deliverables of the Analytical Science group. This is the team that supports process development with a suite of analytical technologies that include HPLC/UPLC, DLS, ELISA, qPCR and cell-based assays. The analytical results allow the upstream and downstream process development colleagues to make the right decisions when it comes to the development of viral vectors, virus-like particles, monoclonal antibodies and other biologics.To that effect, he/she will lead a group of scientists and lab technicians. The job holder will be accountable for all contributions expected from the Analytical Science team in the context of external (Customer) and internal projects.
The objectives of the Manager will be to (i) ensure technical and scientific excellence of analytical workflows and deliverables, (ii) ensure operational efficiency in method development, qualification, and routine operations, within the perimeter of project budgets and the applicable Quality Management System, (iii) continuous team development, (iv) ensure innovativeness in analytics and the application of industry best practice.
Leading Analytical Science within Exothera’s Process Development
- Provide scientific leadership and be accountable for all analytical activities that are performed to support upstream and downstream process development
- Represent the Analytical lab in all operational meetings and exchanges that require input from this expertise
- Contribute to the creation of scientific standards for method development, qualification and routine execution
- Organize analytical practices in accordance with scientific and quality standards of the organization
Management of Operations, Planning & Resources
- Ensure operational excellence of the Analytical Science lab in accordance with the standards of the organization
- Lead operational aspects related to the position:
- Operational planning and management of lab resources
- Budgeting (including preparation and presentation)
- Forecasting of resource requirements and formulating justification
- Develop business cases for implementation of new technologies
- Maintain inventory/standard materials in the lab
- Order specific materials
- Govern team development and evolution of team members
- Evaluate training needs of the team members
- Ensure transparent responsibilities within the team, e.g. by maintaining job descriptions and adequate internal communications and team meetings
- Advocate and live the company values
- Interact with Customers when such support is required by project managers or business development
- Ensure that the team representatives maintain the highest standards of interactions with the Customers
- Act accountable for the preparation of Customer-related materials and deliverables, including but not limited to the following:
- Project proposals [supporting project management or business development when needed]
- Development / Study Plans
- Development / Study Reports
- Results Presentations and other communications with Customers
- Actively contribute to developing the QMS within the organization
- Ensure implementation of all required quality practices in the Analytical Science lab
REQUIREMENTS / QUALIFICATIONS
- At least five years of industry experience in biologics / biopharmaceuticals / pharmaceutics
- At least five years of experience in a lab environment focusing on analytics of biomolecules
- Analytical experience with viral particles, viral vectors, and monoclonal antibodies is highly recommended
- Demonstrated experience with analytical method development and qualification is required in preferably several of the following technical areas: HPLC, ELISA, cell-based assays and/or qPCR
- At least two (2) years of team management experience in life sciences is required
- Advanced degree in life sciences / chemistry / chemical or bio-engineering (MSc or PhD), or equivalent
- Experience with Customer interactions, such as in a CRO or CDMO is required
- Demonstrated planning, organizational and communication skills required
- Fluent English is required, French is a definite asset