Process Development Consultant
Eligibility Requirement: Candidates must hold valid rights to work in the EU/Belgium.
Assignment Purpose
Support the transfer and scale‑up of new processes between R&D and manufacturing. Provide technical expertise, project leadership, and cross‑functional coordination to ensure smooth integration of innovations into production.
Scope of Work
- Act as a technical liaison between R&D and manufacturing teams.
- Review and interpret scientific concepts, translating them into practical, scalable production methods.
- Assess mechanical process steps, equipment capabilities, and scale‑up challenges.
- Provide advisory input on chemistry aspects to support process understanding.
- Lead or support project planning, timelines, and resource coordination.
- Identify risks and propose mitigation strategies during process transfer.
- Ensure documentation, SOPs, and validation protocols align with GMP and regulatory requirements.
- Facilitate clear communication across scientific, technical, and operational stakeholders.
Consultant Profile
- Advanced degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Sciences, or related discipline.
- Demonstrated experience in process development, tech transfer, or MS&T within GMP environments.
- Strong grasp of mechanical process operations; working knowledge of chemistry preferred.
- Proven track record in project management and cross‑functional collaboration.
- Familiarity with regulatory compliance and validation standards in pharma/biotech.
Key Competencies
- Independent, self‑directed, able to deliver results within defined project scope.
- Strong communicator, capable of bridging scientific and operational perspectives.
- Analytical and solution‑oriented, with attention to detail and compliance.
- Flexible and adaptable to changing project priorities.
Engagement Details
- Duration: Fixed‑term project (e.g., 6-12 months, renewable depending on pipeline needs).
- Location: On‑site presence required for manufacturing/R&D interface, with flexibility for remote documentation and planning tasks.
- Deliverables: Successful transfer of new processes into manufacturing, validated documentation, and cross‑functional alignment.
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