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).
To support our growing team, we are looking for a CMC Project Manager for our Ghent site, as the first point of contact between our CDMOs/CROs and ATB, keeping our CMC projects on track.
We are looking for a skillful planner, with several years of CMC experience, and great communication skills.
Your Role
As CMC Project Manager, you will coordinate and oversee drug substance (DS) and drug product (DP) development activities for our Biologics pipeline with external partners and vendors. Working at our Ghent Site, reporting directly to the Chief Development Officer, you will define, communicate, and track project milestones, orchestrate technology transfer and DS manufacturing activities at CDMOs, and ensure deliverables meet quality, regulatory, budget, and timeline commitments. You will be the primary operational interface between ATB Therapeutics and our CDMOs/CROs, keeping stakeholders aligned and projects moving decisively.
This is wat you will be working on:
- CMC Project Coordination & Vendor Management
- Serve as the main point of contact for CDMOs and service providers for CMC activities across development stages.
- Build and maintain integrated CMC project plans (scope, timelines, milestones, budget, risks and drive execution to plan.
- Facilitate tech transfer packages, readiness checks, and change control coordination between ATB and external sites; ensure smooth hand-offs and issue resolution.
- Organize and run vendor governance (kick-offs, weekly workstreams, monthly steering) and maintain clear minutes, actions, and decisions.
- Cross-Functional Collaboration
- Align with internal stakeholders on priorities, critical path, and dependencies.
- Support the Chief Development Officer with concise status dashboards, scenario plans, and executive readouts.
- Coordinate stability, reference standard, and sample logistics with internal/external labs.
- Documentation & Compliance
- Ensure documentation (plans, protocols, reports, batch records, deviations/CAPAs, meeting minutes) is complete, version-controlled, and inspection-ready.
- Support CMC inputs for IND/IMPD and amendments (e.g., DS manufacturing description, control strategy, validation roadmap) in partnership with RA and QA.
- Maintain RAID (Risks, Assumptions, Issues, Dependencies) and change logs.
- Leadership & Continuous Improvement
- Champion PM best practices (stage gates, KPIs, RACI, lessons learned) and consistent tool use (e.g., MS Project/Smartsheet).
- Foster collaborative, high-accountability ways of working with internal teams and partners.
- Identify opportunities to streamline vendor interfaces and data/tech transfer workflows.
Requirements
For a successful fulfilment of this position, we are interested in candidates meeting the following requirements:
- Master’s degree or higher in Chemistry, Biochemistry, Chemical/Process Engineering, Pharmaceutical Sciences, or related field.
- 5+ years’ experience in CMC project/program management or technical CMC role within biotech/pharma, including hands-on CDMO/vendor oversight, knowledge of plant-based production is a plus.
- Demonstrated success running tech transfers, setting/controlling milestones and budgets, and steering external teams to outcomes.
- Solid understanding of GMP principles, Quality Agreements/SOWs, deviations/CAPAs, and inspection readiness; familiarity with IND/IMPD CMC modules.
- Strong planning, communication, and stakeholder management skills.
- Proficiency with project management tools (e.g., MS Project, Smartsheet) and collaborative dashboards.
- Fluency in English, both in speech and in writing, French and/or Dutch are 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.