
Process Development Specialist
4 days ago
Job Description:
We are seeking a skilled Process Development Specialist to join our team. As a key member of our process development team, you will be responsible for the manufacture of APIs and Intermediates, including the technical transfer and validation of new chemical processes.
Key Responsibilities:
- Perform batch manufacturing, cleaning, validation, troubleshooting, and support Operational Excellence projects.
- Ensure plant operations are executed in a safe manner and to expected cGMP standards.
- Work on New Product Introductions collaborating with R&D and other departments.
- Support business development with plant tours for potential customers.
- Participate on site emergency response team.
- Responsible for carrying out real-time data entry and transactions for operations within the shift.
- Ensure the plant is in an audit-ready state and that all documentation is completed to expected cGMP standards.
- Meet plant key performance indicators such as throughput, yield, safety, quality, and changeover targets.
Requirements:
- Bachelor's degree in Chemistry/Chemical Engineering or other science discipline, or 4+ years of experience working in the pharmaceutical industry.
- Good interpersonal and communication skills, with a proven ability to troubleshoot and problem-solve.
- Strong collaborative skills, with an ability to work effectively in a team environment or on one's own initiative without close supervision.
- Previous experience in the scale-up or tech transfer of new products would be an advantage.
- Operational Excellence certification (yellow, green, black belt) would be an advantage.
About Us:
We are a global Contract Development and Manufacturing Organisation with state-of-the-art facilities in Korea, US, France, and Ireland. Our mission is to produce and deliver life-changing therapies that improve patient outcomes and save lives.
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