The successful candidate will lead process development and scale-up activities while providing technical expertise to resolve significant processing issues in a commercial API facility
Job Summary
The successful candidate will lead process development and scale-up activities while providing technical expertise to resolve significant processing issues in a commercial API facility.
This role combines hands-on technical leadership with people and project management responsibilities to ensure safe, compliant, and efficient production of clinical and commercial active pharmaceutical ingredients.
The position requires managing transfers of processes to other company sites or external partners while ensuring all laboratory and operational activities meet current GMP and GLP requirements.
Matching Summary
The successful candidate will lead process development and scale-up activities while providing technical expertise to resolve significant processing issues in a commercial API facility.
Skills & Requirements
Must-have
Process chemistry and engineering principles
cGMP and GLP regulatory compliance
API manufacturing and validation experience
Deviation management and investigation
Process scale-up and optimization
Nice-to-have
Lean leadership and continuous improvement
Cross-cultural team collaboration
Strategic thinking and problem solving
Budget oversight and financial management
Innovative approach to process solutions
Key Requirements
Degree (BSc/BEng) in Chemistry or Chemical Engineering
Strong background in process chemistry and engineering
Experience with equipment and cleaning validation
Knowledge of electronic batch records and DeltaV systems