Technical Lead

il y a 3 semaines

Charleroi, Belgique UNIVERCELLS Temps plein

**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
**Technology Leader Nucleic Acid **supports the Project Managers and is responsible for the coordination of operational activities performed by the Nucleic Acid Production and the Analytical teams to ensure the respect of timelines and objectives achievement. He is responsible for the successful technology transfer of the mRNA production process and analytical activities steps designed by the subcontractors or by the customers. The mRNA production process covers the production of DNA, of mRNA Drug Substance, of Drug Product and of the filling of small batches for clinical trials and commercial use.

The
**Technical Leader **acts also as a leader for the process continuous improvement.

**RESPONSIBILITIES**:

- Coordinate and plan GMP and Non-GMP activities of Exothera NA’s teams to support Project Managers:

- Production team
- Analytical team
- Key Referent for technical question to the customer
- Lead process and analytical development and transfer related to new mRNA product developed for customers and based on a standard process:

- Interface with Discovery teams of subcontractor.
- Process and analytical transfer from subcontractor to Exothera NA.
- Support teams for process troubleshooting, continuous improvement and technical discussion with prospects/clients:

- Data trending and monitoring of running processes to ensure process reliability.
- Determination of product impact in case of significant investigations/deviations/OOS related to the production process.
- Support for changes to existing production and analytical processes by generating scientific / technical study protocols and reports.
- Identify, assess, and implement new technologies in collaboration with the Chief Technical officer to continuously improve services offering.
- Ensure alignment to Market Dynamic
- Is an internal Nucleic Acid referent for pricing, proposal, and contract elaboration and helps the Proposal Team develop and improve the Pricing model.
- Suggests the appropriate project delivery strategy answering to the needs of each Client

**PROFILE**:

- Engineer, MSc in Biotechnology or Process Engineering, or equivalent competencies acquired through experience
- 10+years of successful and relevant experience in pharma GMP manufacturing activities from Starting Material till Drug Product using single-use technology.
- Excellent track record on process development, Technology Transfer and/or MSAT
- Experience in a CDMO preferred.
- Experience with Production of RNA and DNA preferred
- Team player, with strong demonstrated interpersonal skills.
- Right First Time & Customer-oriented.
- Excellent analytical and organizational skills, pragmatism, and positive critical thinking.
- Resilience and agility in demanding environment.
- Exposure to new plant setting-up/qualification/start-up projects is a clear plus.
- Autonomous and Agile
- Excellent communication skills
- Fluent in English and French

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