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 Analytical Science laboratory of Exothera, the HPLC Scientist is responsible for developing, transferring and qualifying analytical methods in support of the bioprocess development activities of Exothera. He/She will work closely with Analytical Technicians to plan and execute method development, method qualification, and routine testing. He will make sure that these analytical deliverables are made available within the agreed project timelines, while respecting all applicable quality and EHS regulations.
The analytical methods are essential supports for upstream and downstream bioprocess development. Our colleagues need the analytical results to design effective and efficient production processes. These assays include e.g. size exclusion and ion exchange based UPLC and HPLC methods, to evaluate product quality attributes such as purity or the ratio between full and empty viral particles. Light scattering is used to evaluate particle size, aggregation and concentration. These methods apply to process intermediates or end-products of our development batches of viral vectors, virus-like particles, vaccines, monoclonal antibodies and other biologics. The Development Lab operates in a BSL2 setting.
The objectives of the HPLC Analytical Scientist will be to
(i) ensure technical and scientific excellence of analytical workflows and deliverables,
(ii) ensure efficient method development, transfer, qualification and routine testing operations, within the perimeter of project budgets,
(iii)contribute to building and improving the systems and procedures of the Development lab.
Leading analytical method development and qualification
- Take the lead in development, transfer and/or qualification of UPLC, HPLC and DLS based methods
- Contribute directly to analytical testing and oversee execution by technicians; peer review of test results
- Train and guide Analytical Technicians
- Write and/or review method transfer or qualification protocols and reports
Internal and External representation
- Act as analytical expert for methods within his area of expertise in meetings with clients.
- Present progress and results in internal project meetings
- Act as scientific coach and soundboard for 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
- Participate in continuous improvement by suggesting new processes or procedures to improve efficiency
- Contribute actively to innovation by looking out for relevant technological innovations and their evaluation or implementation
REQUIREMENTS / QUALIFICATIONS
- At least five years of experience in an analytical lab environment focusing on UPLC/HPLC applications in biologics or gene therapy
- Analytical experience with viral particles, viral vectors, vaccines and monoclonal antibodies is highly recommended
- Demonstrated experience with analytical method development and validation 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 an asset
- Fluent English is required, French is a definite asset