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 Outsourcing Manager is responsible for managing the external analytical laboratories that Exothera collaborates with. The QC Outsourcing manager will contribute to the selecting of analytical partners by identifying and proposing the most appropriate one(s) in line with Exothera’s criteria and maintain the working relationship once tests are being performed by the outside laboratory.
The analytical methods that may be amenable to outsourcing may control incoming raw materials, process intermediates, or serve to release batches of viral vectors, virus-like particles, vaccines, monoclonal antibodies and other biologics. They may include microbial and other testing in the context of environmental monitoring or testing of facility utilities. They may also be in the scope of characterization tests for the Development organization of Exothera.
Reporting to the Head of QC, the QC Outsourcing Manager will operate in a matrix-like structure, with a multitude of interactions, including laboratory Scientists, but also Project Managers, Supply, Logistics and Quality.
The objectives of the QC Outsouring Manager will be to
– (i) ensure excellence in selection of analytical partners,
– (ii) ensure efficient transfer of information from and to the selected analytical lab,
– (iii) ensuring implementation of method development, transfer, validation and routine testing activities at the external lab, within the perimeter of project budgets and the applicable Quality Agreement.
Leading external lab selection
·Identify external analytical labs that meet the analytical testing requirements of Exothera in terms of capability, timing, and price
·Collaborate with Quality Assurance for the quality assessment of the external partner
·Lead Request for Proposal process for analytical services
·Compare competitive offerings and present conclusions to management to allow vendor selection
·Lead the writing or review of Quality Agreement, in collaboration with Exothera’s management and Quality Assurance
Leading method transfer and/or oversee method validation
- Act as lead scientist for methods that are transferred to or from the external analytical lab by method transfer strategies agreed between the parties and laid down in transfer protocols
- Scientifically review validation or stability protocols and reports from the external lab
Managing routine operational relationship with external labs
- Ensuring that there is an agreed flow of information/documentation that is fed to the external lab when sending samples.
- Interfacing between internal QC lab, Exothera’s logistics and the external lab for any issues related to shipments
- Following up on timelines agreed with the external lab by ensuring effective two-way communication
- Act as single-point-of-contact for matters related to laboratory certificates of analysis, or out-of-specification results obtained at the external lab.
- In collaboration with, or on behalf of QC Manager, represent the QC lab in business development or project progress meetings with Customers
- Actively contribute to developing thequality systems within theQC lab.
- Participate in continuous improvement by suggesting new processes or procedures to meet compliance objectives and improve efficiency
REQUIREMENTS / QUALIFICATIONS
- At least three years of experience in a GMP quality control lab environment focusing on analytics of biomolecules
- Demonstrated experience in contract lab interactions
- 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 lifesciences / 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
We offer a long-term contract, a competitive salary package (health insurance, company car, pension plan, meal vouchers…), and the possibility of evolution in an international, dynamic, and fast-growing company. Is it appealing to you? Are you a powerful thinker combined with an efficient doer? Apply now!