
Expert Formulation Developer
7 hours ago
We are seeking a highly experienced Pharmaceutical Process Development and Scale-up Specialist to join our team. This key role involves designing and optimizing manufacturing processes for regulated markets.
The successful candidate will be responsible for evaluating manufacturing processes using Design of Experiments (DoE) and Quality by Design (QbD) principles to define design space, control strategy and identify process risks. They will also lead the technology transfer function, ensuring seamless scale-up of new products and effective launches within stipulated timeframes.
As a subject matter expert in pharmaceutical processes and technologies, you will provide guidance on tech transfer, troubleshooting and investigations to ensure robust performance and timely supply. Your key responsibilities will include defining procedures for efficient product transfers between development and manufacturing, reviewing and approving departmental Standard Operating Procedures (SOPs), and driving capacity enhancement, cost reduction and time cycle reduction projects.
- Essential Skills:
- Formulation development of various dosage forms
- Process optimization
- Technology transfer and scale-up
- Regulatory compliance with USFDA, EMA and WHO guidelines
- Project management and cross-functional coordination
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