ATB Therapeutics is a Biotech company developing a cutting-edge technology to produce a new kind of targeted therapy designed to treat cancers and auto-immune diseases. ATB Therapeutics has two Belgian R&D sites located in the Novalis Science Park (Marche-en-Famenne) and the VIB incubator (Ghent).
To support our growing team, we are looking for a Manufacturing Engineer to facilitate the establishment, development, and day-to-day operations of our new Pilot Plant, a proprietary plant-based production facility at our Marche-en-Famenne R&D site.
We are looking for someone who can take us from design and commissioning to the day-to-day operations of this new facility, while keeping a close eye on QA and GMP.
Your Role
As Manufacturing Engineer, you will support the establishment, development, and day-to-day operations of our new Pilot Plant, a proprietary plant-based production facility at our Marche-en-Famenne R&D site. Reporting to our Pilot Plant Project Manager, the first phase of the role will focus on the design and commissioning of the new Plant. This will require close collaboration with the R&D team to ensure process scalability and adherence to GMP regulatory standards. The second phase will involve commissioning and initiating day-to-day operations. You will serve as the subject matter expert for your area, leading the resolution of production issues and the introduction of new products. You will also be responsible for training personnel.
This is wat you will be working on:
- Process industrialization & Scale-up:
- Lead the implementation of ATB’s proprietary production process for your area
- Collaborate with R&D process teams to transition laboratory-scale processes into the pilot plant for scaling to meet the needs of early-stage production and product development
- Industrialize processes from R&D to pilot production while optimizing and troubleshooting processes to enhance yield, product quality, and operational efficiency
- Identify and manage risks associated with scale-up and process validation.
- Ensure EHS requirements are integrated
- Facility and Equipment Design
- Lead the design of Equipment of your area that will be implemented in the Pilot Plant
- Write the equipment’s URS in your scope
- Interact with suppliers to optimize equipment’s design
- Manage the budget and the timeline for the equipment in your area
- Ensure EHS requirements are embedded in the design
- Actively participate in the design of the facility
- Review and approve design Documents
- Perform the design with compliance with EU and US regulatory requirements
- Start-up Pilot Plant
- Develop the Production recipes and the associated Bill of Material for your area
- Develop and maintain Standard Operating Procedures (SOPs) to operate the Pilot Plant and to transfer new products from R&D to Pilot Plant
- Actively participate in the Commissioning and qualification phase of the Pilot Plant
- Review and approve protocols and technical documents
- Ensure the training of the team for your area
- Write deviations and CAPAs
- External Collaboration & CDMO interaction
- Take part in the selection and management of service providers
- Interact with CDMO, including tech transfer, scale-up, engineering, and GMP runs
- Collaborate with our CMC manager to follow the production ongoing at CDMO’s and solve potential issues
Requirements
For a successful fulfilment of this position, we are interested in candidates meeting the following requirements:
- Bachelor or master’s degree in Bioengineering, Biochemical Engineering or related discipline with at least 5 years of experience in bioprocess production in GMP conditions
- Ideally, you have experience in either plant farming, fermentation or monoclonal antibody development, process development is a plus
- Proven track record of designing process development from R&D to industrial-scale production
- Knowledge of process validation and regulatory submission for IND/IMPD filings.
- Expertise in quality assurance and GMP compliance
- Solid communication and interpersonal skills, with the ability to work effectively in a collaborative, multidisciplinary environment
- Fluency in English and French, both in speech and in writing, Dutch is a plus
Our offer
Besides becoming part of a driven and growing, close-knit team, we offer a competitive salary with 32 holidays, a permanent contract, health insurance and meal vouchers, as well as several fun team events per year.
About ATB Therapeutics
Founded in 2018, ATB Therapeutics is a pioneering biotechnology company dedicated to the discovery and development of novel antibody therapies. Leveraging a proprietary technology platform based on plant molecular farming, ATB Therapeutics aims to deliver targeted solutions to high unmet medical needs, including oncology and autoimmune diseases, through innovative, next-generation weaponized antibody treatments.