Job description
1. Mission Context
We are looking for a Senior Consultant to reinforce the Downstream Production Support (DSP) team.
The role is equivalent to internal Operational Support Leads and is required due to the increasing workload and complexity of DSP topics. It is broader and more senior than a Deviation Writer role, with full ownership of topics from issue identification to implementation in production.
You will be a key actor in ensuring robust, compliant, and efficient DSP operations in a biopharmaceutical environment.
2. Key Responsibilities:
End-to-End Operational Support – DSP
* Provide end-to-end operational support for Downstream Processing production activities.
* Manage and coordinate quality and operational topics, including:
o Deviations (partial scope, not 100%)
o CAPAs (definition, follow-up, closure)
o Change Controls (initiation, impact assessment, implementation follow-up)
o Production documentation (batch records, SOPs, work instructions, etc.)
o Risk assessments (process and quality risk analyses)
Implementation of Solutions in Production
* Support and drive the implementation of solutions in the field (process improvements, corrective actions, changes).
* Ensure practical feasibility, alignment with GMP, and proper integration into routine operations.
* Take ownership of actions until full implementation in production.
Cross-Functional Interface
* Act as a key interface between:
o Production (shop-floor teams, supervisors, managers)
o QA / MSAT (Quality Assurance, Manufacturing Science & Technology)
o Suppliers (equipment, consumables, technology providers – depending on topics)
* Ensure clear, proactive communication and alignment across stakeholders.
3. Typical Day
* Manage multiple topics in parallel, setting and adjusting priorities based on risk and impact.
* Perform administrative work in Quality Systems (deviation/CAPA/CC management, documentation updates, electronic systems).
* Write and review documentation in French and English (deviations, CAPAs, CCs, protocols, reports, SOPs).
* Spend time in production areas to:
o Understand processes and issues
o Observe operations and collect data
o Support and verify implementation of actions and changes
* Coordinate with a wide range of stakeholders (production, QA, MSAT, engineering, suppliers) to move topics forward and secure on-time delivery.
4. Profile Requirements (Must-Have)
Technical & Industrial Background
* Mandatory Downstream Processing (DSP) experience, including hands-on exposure to:
o Chromatography
o UF/DF (Ultrafiltration/Diafiltration)
o Filtration, including viral filtration
o Formulation and filling steps
* Senior profile with 7–10 years of relevant experience.
* Solid industrial production experience in biopharma/biotech (a QC-only background is not acceptable).
* Proven experience in GMP-regulated environments and operational support roles.
Ways of Working
* Strong autonomy: able to manage topics end-to-end with limited supervision.
* Excellent prioritization skills and ability to handle multiple complex topics simultaneously.
* Comfortable working in quality systems and with structured documentation.
Languages
* Fluent French (daily interactions, documentation, meetings).
* Professional English (documentation, suppliers, international stakeholders).
5. Nice-to-Have
* Experience in large pharmaceutical organizations or complex industrial sites.
* Strong solution-oriented mindset and ability to structure and manage complex topics (technical and organizational).
* Experience in transversal roles interfacing with multiple departments (Production, QA, MSAT, Engineering, Supply, etc.).
6. Ideal Candidate
* Highly autonomous, able to take ownership and drive topics to completion.
* Agile and resilient, comfortable in a dynamic environment with changing priorities.
* Delivery-oriented, focused on concrete results and implementation in the field.
* Comfortable in transversal roles, working across teams and hierarchies.
* Strong “doer” mindset:
o Not limited to mailbox or advisory support
o Actively pushes topics forward, challenges blockers, and secures implementation in production
* Able to drive topics through full implementation in production, ensuring sustainability and compliance.
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.