Production Specialist

PanTera is looking for a Production Specialist – Early Supply to develop and maintain deep technical expertise in PanTera’s Early Supply manufacturing processes.

The Production Specialist combines strong process and chemistry knowledge with hands-on presence in the production environment. The role focuses on process expertise, technical troubleshooting, root cause analysis, process improvement and manufacturing support.

The Production Specialist works closely alongside operators, production supervisors, and other technical functions to understand manufacturing performance, solve problems and continuously improve the reliability and robustness of the production process.

Responsibilities

Process & Manufacturing Expertise

• Develop and maintain an in-depth understanding of the Early Supply manufacturing process, including its chemistry, equipment, process parameters, materials and critical process steps.
• Become a key technical reference for the manufacturing process and support the Production team with process-related questions and challenges.
• Understand the interaction between process chemistry, equipment performance and operational execution.
• Maintain a strong presence in production and laboratory areas to observe manufacturing activities and develop practical understanding of process performance.
• Support the assessment of unusual process observations, unexpected results and operational issues.
• Support preparation and revision of manufacturing documentation, including SOPs, work instructions, forms, specifications, and technical documentation.
• Translate process knowledge and manufacturing experience into clear technical recommendations and improvements.

Technical Troubleshooting & Problem Solving

• Support and, where appropriate, lead the technical investigation of process and equipment-related manufacturing issues.
• Apply structured problem-solving methodologies to identify potential and confirmed root causes.
• Perform systematic root cause analysis using manufacturing data, process observations, equipment information and operator feedback.
• Support troubleshooting activities during and following production runs.
• Identify trends, recurring issues and potential weaknesses in the manufacturing process.
• Work with Production, Engineering, Maintenance, QC and other technical experts to develop practical solutions to manufacturing problems.
• Follow technical issues through to resolution and verify the effectiveness of implemented solutions.

Deviations, Investigations & CAPA

• Provide technical input to deviation investigations related to manufacturing processes and equipment.
• Collect, organize and analyze relevant information required for investigations.
• Support the identification of root causes and contributing factors.
• Define or support appropriate corrective and preventive actions (CAPAs).
• Prepare clear technical summaries, investigation reports and supporting documentation.
• Ensure that conclusions and recommendations are scientifically and technically justified.

Equipment & Qualification Support

• Develop a detailed understanding of equipment used within the Early Supply manufacturing process and its impact on process performance.
• Support troubleshooting of process equipment
• Provide manufacturing and process input during equipment modifications, maintenance activities and technical interventions.
• Support commissioning, qualification and requalification activities where process expertise is required.
• Support evaluation of equipment performance following interventions or modifications.

Qualifications and Skills

Education & Experience

• Bachelor’s or Master’s degree in Chemistry, Chemical Engineering, Process Engineering, Radiochemistry or another relevant scientific or technical discipline.
• Previous experience in a manufacturing, laboratory, chemical processing or technical production environment is preferred.
• Experience in GMP manufacturing, radiochemistry, nuclear medicine or pharmaceutical production is highly desirable.

Other Requirements

• Proficiency in English; Dutch is an advantage.
• Eligible for required security clearance.
• Comfortable working with and around radioactive materials and hazardous chemicals.
• Willing and able to work within controlled areas and comply with applicable radiation protection requirements.
• Flexibility to support manufacturing activities when technical issues or investigations require presence in production.
• This is an on-site role wi