Qc Outsourcing Scientist

**Exothera **is a contract research, development, and manufacturing organization (CRDMO) dedicated to viral vectors and nucleic acids production. As a technology-driven company, **Exothera **provides best-in-class bioprocessing expertise that capitalizes on the best and most innovative manufacturing technologies developed within the Univercells group. The company delivers accelerated discovery services as well as process development/optimization to rapidly reach GMP clinical and commercial production of viral vectors and nucleic acids. At **Exothera **and Univercells, Our mission is to make life-changing therapies available to all.

We work every day on reinventing biomanufacturing processes and develop or integrate the next innovative technologies. With the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: Biologics available and affordable to all This job is the perfect opportunity to contribute to our mission and be impactful.

Based in Jumet, you will join a collaborative team, full of passionate change-makers. You will be a key member of an international and dynamic team in a fast-growing and innovative organization of 150+ people, fully supported by prominent investors and international organizations.

**MISSION**:
The major objectives of the QC Outsourcing Scientist are:

- ensure excellence in selection of analytical partners,
- ensure efficient transfer of information from and to the selected analytical laboratory.
- 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.
- contribute to build and improve the outsourcing leadership of the QC.
- Participate to external meetings with subcontractors.
- Follow up nonconformities’ declaration and closure on time.

**RESPONSIBILITIES**:

- 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
- 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
- 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.

**QUALIFICATIONS, SKILLS & EXPERIENCE**:

- Degree in life sciences / chemistry / chemical or bio-engineering (MSc or PhD), or equivalent, with the required skills, knowledge and abilities that are typically acquired through experience in a biopharmaceutical manufacturing environment with cell culture activities
- Analytical mindset, accurate and precise
- Problem solving attitude.
- Teamwork
- Ideally a first experience in a GMP quality control lab environment focusing on analytics of biomolecules.
- Experience in contract lab interactions
- Analytical experience with viral particles, viral vectors, vaccines and monoclonal antibodies is highly recommended
- Experience with Customer interactions, such as in a CRO or CDMO is an asset
- Fluent in French and English