Technology & Manufacturing Science Lead - Exothera
Il y a 2 mois
Exothera_
- is a contract research, development, and manufacturing organization (CRDMO) dedicated to virus, viral vector, and nucleic acids production. As a Univercells company, Exothera provides best-in-class bioprocessing expertise that capitalizes on novel manufacturing technologies. The company delivers accelerated discovery services as well as process development/optimization to rapidly reach GMP clinical and commercial production of viruses, viral vectors, and nucleic acids. At Exothera and Univercells, our mission is to make health equally accessible to all._
At Exothera in Jumet, we are currently looking for a Technology & Manufacturing Science Lead. This is an exciting position within our brand-new Nucleic Acid Business Unit. Here below all the details.
**MISSION**
The Technology Leader & Manufacturing Science supports the Project Managers and is responsible for the coordination of operational activities performed by the Production and the Analytical teams to ensure the respect of timelines and objectives achievement. He is responsible for the transfer to ExoThera of the product, whose discovery and development are outsourced. He is responsible for the successful technology transfer of the mRNA production process steps designed by the subcontractors or by the customers. The mRNA production process covers the production of DNA, mRNA Drug Substances, Drug Products and of the filling of small batches for clinical trials and commercial use.
The Technical Leader acts also as a leader for the process of continuous improvement.
**RESPONSIBILITIES**
- Coordinate and plan activities of Exothera’s teams to support Project Managers. In particular with, Production and Analytical Development team as well as the support team (QA, QC, Tech Services, etc.)
- Lead product transfer related to new mRNA product developed for customers and based on a standard process. Interface with Discovery teams of subcontractors. Technology transfer from subcontractor to Exothera NA
- As production front line, support teams for process troubleshooting, continuous improvement, and technical discussion with prospects/clients such as:
- 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.
- Production team training & coaching
- Support for changes to existing production processes by generating scientific/technical study protocols and reports
- Identify, assess, and implement new technologies to continuously improve production performance: product quality, reproducibility, reliability, cost, and time of manufacturing processes
**QUALIFICATIONS AND SKILLS**
- 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 to Drug Products and single-use technology.
- Excellent track record in process development, Technology Transfer, and/or MSAT.
- 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 a demanding environment.
- Exposure to new plant setting-up/qualification/start-up projects is a clear plus.
- Fluent in English and French.
- 10+ years of successful and relevant experience in pharma GMP manufacturing activities from Starting Materials to Drug Products and single-use technology.
- Excellent track record in process development, Technology Transfer, and/or MSAT.
**QUALIFICATIONS AND SKILLS**
- 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 to Drug Products and single-use technology.
- Excellent track record in process development, Technology Transfer, and/or MSAT.
- 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 a demanding environment.
- Exposure to new plant setting-up/qualification/start-up projects is a clear plus.
- Fluent in English and French.
- 10+ years of successful and relevant experience in pharma GMP manufacturing activities from Starting Materials to Drug Products and single-use technology.
- Excellent track record in process development, Technology Transfer, and/or MSAT.
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