Key Responsibilities:
* Partnering with the Operations, Quality, and Planning departments for daily operational support of API drug substance synthesis (e.g. campaign preparation, resolution of non-conformances, CAPA implementation, process optimizations, production follow up, etc.)
* Leading complex process investigations or product related technical issues
* Identifying and implementing Cost Improvement Projects (CIP) (e.g., yield improvements, cycle time reduction, de-bottlenecking, etc.) and process optimizations.
* Applying approaches such as process modelling / digital twins, advanced data-driven methodologies (e.g., multivariate analysis, data analytics, AI/ML technology etc.), and process analytical technologies (e.g. infrared spectroscopy, focused beam reflectance measurement) to facilitate improved process understanding, optimizations, and non-conformance investigations.
* Building process technology expertise and supporting the evaluation and introduction of new process technologies.
* Collaborating closely with the global technology, data, and development functions to design specific technology solutions for optimized syntheses.
* Leading/supporting slow moving and obsolete inventory (SLOB) avoidance activities.
* Leading internal technology transfers and supporting external technology transfers.
* Monitoring process and product performance (Continuous Process Verification, Product Quality Reviews).
* Contribution, review, and approval of technical documentation
* Technical support in partnership with Quality in regulatory audits and inspections
Qualifications:
* Master’s Degree or PhD preferably in Chemical engineering or Process technology (bioengineering, industrial engineering or chemistry), or proven record in an industrial, operational environment.
* Previous experience or strong interest in chemical synthesis / API synthesis and/or process technology. Experience in an API manufacturing or development environment is an asset.
* Experience or knowledge in one or more of the following areas related to API manufacturing is preferred: organic chemistry, reaction engineering, distillation, liquid-liquid extraction, solid-liquid separation, drying
* Knowledge or strong interest in one or more of the following areas is an asset: process modelling, process analytical technology (PAT), data analytics, multivariate analysis, AI/ML, lean manufacturing (certification is a plus), process excellence (certification is a plus).
* Awareness of API manufacturing site systems and procedures (SAP, complaint handling, change control, qualification, process validation, etc.)
* Good project management, planning, and coordination skills.
* Motivated, able to work independently and take decisions autonomously, with demonstrated problem solving skills and results driven personality.
* Strong interpersonal skills, e.g., influencing and handling conflicting interests.
* Strong analytical skills with a high level of accuracy.
* Able to establish close collaborations with internal and external business partners
* Working knowledge of English (both verbally and written) and Dutch (or willing to develop proficiency in Dutch)