Principal Scientist, Drug Product

Principal Scientist, Drug Product Principal Scientist, Drug Product Apply locations: Hopewell | Time type: Full time | Posted on: Posted 27 Days Ago | Job requisition id: R27163 BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. During this transition, both "BeiGene" and "BeOne" may be used to describe the company. BeOne continues to grow rapidly, offering challenging and exciting opportunities for experienced professionals. We seek scientific and business professionals who are highly motivated, collaborative, and share our passion for 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 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 technical operations supporting both clinical and commercial manufacturing activities. Leadership: Serve as MST DP SME and process lead for drug product, ensuring materials, strategy, and documentation are in place. Collaborate with DP/SC/QC/QA to develop testing strategies 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 related activities. Support engineering teams on equipment selection, qualification, and start-up activities. Monitor and 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 MST and Technical Development to enable new DP filling capability at Hopewell. Provide technical support for Drug Product Operations, including operational metrics, budgeting, and planning. Establish a data and metrics-driven culture. Maintain alignment with global manufacturing sites through shared knowledge, data, issues, and solutions. Partner with GZ Technical Development to transfer and validate HPW DP processes, including parenteral vials and lyophilized products. Collaborate on investigating and resolving complex manufacturing issues at CMOs. Manage and coordinate global change processes, ensuring stakeholder alignment. Assist in regulatory filings and health authority inspections to license and maintain BeOne's pipeline and product portfolio. Essential Functions: Lead technology transfer for cGMP manufacturing focused on drug product fill/finish. Ensure effective communication, risk assessment, timeline execution, issue resolution, and documentation across cross-functional teams. This includes leading tech transfer, process definition, and facility fit assessments. Execute scale-down models of manufacturing processes and maintain good laboratory practices. Author and maintain process control strategy documents and process risk assessments throughout product lifecycle. Author PPQ protocols and oversee their execution. Support engineering on equipment qualification and start-up. Monitor and trend process performance, including parameters and deviations. Investigate root causes of major deviations, implement CAPA, and identify opportunities for system improvements. Work collaboratively with Process Development, Process Sciences, Manufacturing, Quality, and Project Management teams to facilitate successful technology transfer and projects. Preferred Skills/Experience: Facility start-up experience Commissioning, qualification, and validation expertise Equipment and process design knowledge Experience with quality risk assessments, health authority interactions, audits Knowledge of OE and LEAN methodologies Experience with Distributed Control Systems / Control Systems Deviations assessments and investigations Familiarity with SAP, LIMS, CMMS, Veeva Expertise in aseptic filling operations, isolator technology, packaging, and inspection machines Knowledge of IQ/OQ/PQ and process engineering Experience with late-stage/ commercial drug product technology transfer, process characterization, and validation Understanding of GMP and regulatory requirements Ability to work independently and in teams, manage multiple projects, troubleshoot complex issues, analyze data, and communicate effectively. Qualifications: BA/BS or higher in science, biochemistry, biotechnology, biology, chemical engineering, or related fields Minimum 7 years of experience in biopharmaceutical DP process development or manufacturing Physical Requirements: Ability to stand for 8-10 hours, reach, bend, push, pull, handle, lift up to 40 lbs, and work in varying temperatures. Frequent movement, repetitive motions, and working with hazardous materials are required. Computer Skills: Proficiency with Word, Excel, PowerPoint. Travel: International and domestic, periodically. Global Competencies: Our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit guide us. Our global competencies include teamwork, feedback, self-awareness, inclusion, initiative, entrepreneurial mindset, continuous learning, adaptability, results orientation, analytical thinking, financial excellence, and communication. Salary Range: $132,200 - $177,200 annually BeOne is committed to fair and equitable compensation practices, with packages determined by skills, experience, education, and location. Benefits include medical, dental, vision, 401(k), FSA/HSA, life insurance, PTO, wellness, and employee stock options. We are an equal opportunity employer, committed to diversity and inclusion in our hiring practices. #J-18808-Ljbffr