Head of Pilot Plant

☞ atbtherapeutics

看过: 100

更新日: 26-11-2025

位置: Marche-en-Famenne Luxembourg

类别: 执行管理 生产/工艺

行业: Biotechnology Research

水平: Mid-Senior level

工作类型: Full-time

Loading ...

工作内容

Department:Research & Development

Location:Marche-en-Famenne

Description

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).

As Head of ATB’s Pilot Plant, you will lead the development of our proprietary production process towards the establishment of a pilot unit dedicated to support clinical trials. You will contribute to the development of our current pipeline candidates and leverage the potential of ATB’s technology to produce them at industrial level.

Your Role

As Head of ATB’s Pilot Plant, you will lead the establishment and development of our proprietary plant-based production facility at the Marche-en-Famenne R&D site. You will play a critical role in transitioning innovative drug candidates from R&D through pilot-scale production while ensuring compliance with EU and US regulatory standards. Reporting directly to the Chief Operating Officer, you will build and lead a multidisciplinary team focused on process development and scale-up.

Here’s in more detail what you will be working on:

  • Process Development & scale-up
    • Lead the development and implementation of ATB’s proprietary production process.
    • 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.
    • Lead the design of the pilot plant, select and manage the engineering firm, oversee the construction, and operation according to industry standards.
    • Develop scalable upstream processes from R&D to pilot production while optimizing and troubleshoot processes to enhance yield, product quality, and operational efficiency.
    • Select and Manage service provider to develop the Downstream process.
    • Ensure compliance with EU and US regulatory requirements for investigational drug candidates.
    • Develop and maintain Standard Operating Procedures (SOPs) and technical documentation for process development and pilot plant operations.
    • Identify and manage risks associated with scale-up and process validation.
  • External Collaboration & CDMO coordination
    • Interact with CDMO, including tech transfer, scale-up, engineering, and GMP runs.
    • Collaborate with our CMC manager to coordinate analytical method development internally and externally.
    • Lead technical discussions with external partners and regulatory authorities.
  • Leadership & Team Development
    • Manage timelines, resources, and budget, ensuring milestones are met and deliverables are on schedule.
    • Build, lead, and mentor a high-performing production team.
    • Foster a collaborative, multidisciplinary work environment.
    • Establish a culture of continuous improvement and operational excellence.
Requirements

For a successful fulfilment of this position, we are interested in candidates meeting the following requirements:

  • Ph.D. in Molecular Biology, Biochemistry, Pharmacology, or a related field with at least 10 years of experience in bioprocess development and pharmaceutical manufacturing, preferably in the field of antibody development, plant farming experience is a bonus.
  • Proven track record of designing process development from R&D to industrial-scale production.
  • Experience in dealing with EU and US regulatory authorities on manufacturing-related submissions
  • Knowledge of process validation and regulatory submission for IND/IMPD filings.
  • Expertise in quality assurance and GMP compliance.
  • Strong leadership skills, with experience managing and developing high-performing teams.
  • Solid communication and interpersonal skills, with the ability to work effectively in a collaborative, multidisciplinary environment.
  • Excellent project management skills, with the ability to prioritize tasks and manage multiple projects simultaneously.
  • Fluency in English, both in speech and in writing, French and/or Dutch are a plus.
  • You are authorized to live and work in Belgium.

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.
Loading ...
Loading ...

最后期限: 10-01-2026

点击免费申请候选人

申请

报告工作
Loading ...

相同的工作

Loading ...
Loading ...