Associate Director, Drug Product, Manufacturing Sciences and Technology

Manufacturing Science And Technology (MST) Role

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

Education / Experience Required

Preferred Skills / Experience

Physical Requirements

Computer Skills

Familiarity with computer-based systems. Word, Excel, and PowerPoint a must.

Other Qualifications

Health authority inspections (FDA, EMA, ICH regulations and guidelines). Execution and optimization of controlled procedures. Technical and business writing. Business process development.

Travel

International and domestic periodically.

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Salary Range : $141,500.00 - $191,500.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA / HSA, Life Insurance, Paid Time Off, and