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This role is pivotal for delivering high-quality formulation and manufacturing solutions that support early phase clinical development through GMP production.
Job Responsibility:
Lead, plan and oversee GMP production projects from formulation development through clinical batch manufacturing – ensuring deliverables are on time, within budget, and compliant with GMP standards
Translate project specs from Project Managers into actionable tasks for Development & GMP teams
supervise Associate Scientists in formulating and manufacturing oral and injectable dosage forms
Develop and refine formulation strategies, select excipients and delivery formats, and guide tech transfers from R&D to GMP production
coach the team to maintain standards in non-conformance management and quality assurance alignment
Coordinate with QA / QP and supply chain to ensure availability of starting materials, manage deviations, and resolve GMP / compliance issues swiftly and effectively
Act as scientific & technical problem-solver: troubleshoot formulation, process, equipment, and compliance challenges when they arise
Represent the Formulation & GMP Manufacturing team in project core meetings
provide scientific input to clients and internal cross-functional teams
Requirements:
MSc or PhD in Pharmaceutical Sciences, Chemical Engineering, or a related discipline
significant hands-on experience in formulation development and GMP manufacturing
At least 8-10 years in the pharmaceutical industry, including experience working with oral and/or injectable dosage forms in GMP production settings
Proven leadership experience managing and mentoring scientific teams in both R&D and GMP production environments
In-depth knowledge of GMP regulations, drug product formulation, process optimization, tech transfer and regulatory documentation practices
Strong organizational, communication, and scientific reporting skills
capable of driving technical excellence in a growing team
Fluent in English
Nice to have:
additional proficiency in Dutch/French/German is an advantage
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