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 programs for manufacturers to achieve successful market entry.
Operating within the perimeter of the Quality Control laboratory of Exothera, the QC Scientist is responsible for implementing, transferring and validating analytical methods in support of the biomanufacturing activities of the organization. The QC Scientist will work closely with QC Technicians to plan and execute routine testing and to deliver validated test results within the agreed timelines, while respecting all applicable quality and EHS regulations.
The analytical methods are used to control incoming raw materials, process intermediates, or serve to release batches of viral vectors, virus-like particles, vaccines, monoclonal antibodies and other biologics. The QC Scientist will support microbial and other testing in the context of environmental monitoring or testing of facility utilities. The QC lab operates in a BSL2 setting.
The objectives of the QC Scientist will be to
(i) ensure technical and scientific excellence of analytical workflows and deliverables,
(ii) ensure efficient method development, transfer, validation and routine testing operations, within the perimeter of project budgets and the applicable Quality Management System,
(iii) contribute to building and improving the systems and procedures of the QC lab.
Leading analytical method implementation and execution
- Take the lead in implementation, transfer and/or validation of analytical methods by writing appropriate protocols
- Contribute directly to analytical testing and oversee test execution by QC technicians; peer review of test results
- Train and guide QC technicians
- Troubleshoot methods and investigate OOS results
- Write and/or review method transfer or validation reports
QC lab Operations
- Design stability studies for product intermediates or drug substance, write stability protocols and manage the stability study, up to writing or reviewing stability study reports
- Contribute to cleaning validation study design, testing and reporting
- Contribute to establishing equipment URS and equipment qualification as appropriate
- Contribute to managing the reference samples
- Act as analytical SPOC for external organizations that perform outsourced testing; monitor progress and interface for sample logistics and issues related to testing
- In collaboration with, or on behalf of QC Manager, represent the QC lab in business development or project progress meetings with Customers
- Act as scientific coach and soundboard for QC Lab Technicians, making sure they can execute their operational duties efficiently
- Develop training materials for instruments and methods, where appropriate, and deliver training
- Advocate and live the company values
Quality & Innovation
- Actively contribute to developing the quality systems within the QC lab.
- Participate in continuous improvement by suggesting new processes or procedures to meet compliance objectives and improve efficiency
- Contribute actively to innovation by looking out for relevant technological innovations and their evaluation or implementation
REQUIREMENTS / QUALIFICATIONS
- At least three years of experience in a GMP quality control lab environment focusing on analytics of biomolecules
- Analytical experience with viral particles, viral vectors, vaccines and monoclonal antibodies is highly recommended
- Demonstrated experience with analytical method development and validation is required in preferably several of the following technical areas: HPLC, ELISA, cell-based assays, qPCR and/or microbiology
- 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 an asset
- Fluent English is required, French is a definite asset