Associate Director, Drug Product, Manufacturing Sciences and Technology

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

This role in the Manufacturing Science and Technology (MST) department supports BeOne’s Drug Product Manufacturing Technology Transfer and support. based in New Jersey (Hopewell), this role will be to lead the Hopewell drug product MST function to support technology transfer, validation, continued process verification, investigations, change management and site startup of Hopewell internal drug product manufacturing activities. Reporting to the MST leadership, this role is responsible for managing the technical operations supporting both clinical and commercial manufacturing activities.

Required Leadership Skills:

• 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. Collaborate with Drug Product Operations to establish robust and compliant manufacturing performance.

• Collaborate with Global DP MS&T and Technical Development to enable new DP filling capability at Hopewell Location.

• Provide technical support for Drug Product Operations. Provide input into operational metrics, budgeting, and planning.

• Establish a data and metrics driven culture. Relentlessly maintain alignment with other global manufacturing sites through shared knowledge, shared manufacturing data, shared manufacturing issues, and common solutions.

• Partner with GZ Technical Development to successfully transfer and validate HPW DP processes. Product scope includes parenteral vials and lyophilized products. Collaborate with Technical Development in investigating and resolving complex manufacturing issues at CMOs.

• Manage and coordinate global change ensuring stakeholders alignment. Assist in Regulatory filings and Health Authority site inspections to license and maintain BeOne’s pipeline and product portfolio.

Required Skills/Experience:

• 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

• Ensure effective information flow, risk assessment, timeline execution, issue resolution and documentation for cross-functional teams. Includes leading tech transfer, detailed process definition and facility fit assessment exercises.

• Execute scale down model of manufacturing processes. Maintains a good laboratory practice.

• 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 trend process performance, including input and output parameters.

• Investigate root causes of major deviations for cGMP manufacturing, and implement CAPA for major deviations

• Identifying opportunities to improve systems and practices

• Work with counterparts in Process Development, Process Sciences, Manufacturing, Quality, Project Management teams etc. to facilitate technology transfer and project success.

• Expertise in late stage/commercial Drug Product technology transfer, process characterization and process