BeOne is looking to solve the problem of technology transfer and support for its Drug Product Manufacturing, specifically in the Hopewell, New Jersey location, to support clinical and commercial manufacturing activities.
Requirements
- Expert level knowledge in all Drug Product aseptic filling operation
- Expert level knowledge of Isolator, packaging and automated inspection machines.
- Lead technology transfer for cGMP manufacturing focused drug product fill/finish.
- Expert level knowledge in IQ/OQ/PQ and process engineering
- Execute scale down model of manufacturing processes. Maintains a good laboratory practice.
- Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.
- Familiarity with computer-based systems. Word, Excel, and PowerPoint a must.
Responsibilities
- Serve as MST DP SME and process lead for drug product, ensuring the materials, strategy and documentation are in place.
- Collaborate with DP/SC/QC/QA to develop testing strategy for DP raw materials and in-process samples.
- Author and maintain process control strategy documents throughout the lifecycle of a program and maintain process risk assessment documents.
- Author PPQ protocols and reports. Oversee execution of PPQ and PPQ related activities
- Support engineering teams on equipment selection, qualification, and start up activities.
- Monitor and CPV trend process performance, including input and output parameters.
- Responsible for technical transfer, validation, investigation, and technical support of aseptic manufacturing operations in Hopewell and CMOs.
Other
- BA/BS or higher in science, biochemistry, biotechnology, biology, chemical engineering and/or related discipline.
- Minimum of 8+ years of experience working in Biopharmaceutical DP process development or manufacturing experience.
- Ability to work both independently and as part of a team.
- Ability to function in a fast-paced dynamic team environment and balance prioritize multiple projects
- Must be able to stand for long periods, up to 8 to 10 hours/day.
