Senior Manager, Process Engineering Drug Substance and Drug Product

BeOne Medicines is seeking a highly motivated and organized Senior Manager of Process Engineering for Dug Substance and Drug Product to join our team at the Hopewell, NJ site. The successful candidate will be responsible for leading a hands-on team of subject matter experts focused on supporting technology transfers and new equipment selections, troubleshooting and supporting day-to-day manufacturing, supporting deviation/investigation root cause analysis, regulatory inspections, and continuous improvement. This role works independently, with minimal supervision and direction and will provide technical direction, Project Management support.

Responsibilities

• Effective leadership of technical teams with focus on right-first time Quality.

• Prior hands-on experience in the design, selection, and troubleshooting of systems and equipment used in commercial Drug Substance and Drug Product manufacturing.

• Support of technology transfer and qualification studies associated with the development and implementation of processes, systems, and facilities related to drug product manufacturing.

• Partner with Operations, Quality, and Automation functional areas.

• Develop and review technical documentation

• Participate and lead in controls fault analysis and remediation

• Directly support operations with troubleshooting and issue resolution

• Requires working in an industrial manufacturing environment including gowning

• Support operations and ensure compliance with regulatory, corporate and site requirements

Required Skills/Experience

• Minimum 7 years of experience GMP pharmaceutical operations support. in biopharmaceutical manufacturing, engineering, and/or project management and at least 5 years of project management experience in biologics or GMP.

• Effective leadership of technical teams.

• Passion and expertise developing a team of Engineers

• Effectively gives and receives feedback.

• Proactively identifies, shares, and implements improvement opportunities that supports the site.

• Proven ability to manage multiple complex priorities simultaneously under tight timelines.

• Analytical problem-solving skills and proactive decision-making.

Preferred Skills/Experience

• OE and/or LEAN Methodologies

Physical Requirements :

• Ability to work in an office environment, construction site, and laboratory or manufacturing areas.

• May require up to 5% travel, including visits to partner or manufacturing sites.

• Must be able to sit, stand, and use standard office equipment for extended periods.

Computer Skills:

• Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word, Outlook).

• Experience with project management tools such as Microsoft Project, Autocad, Smartsheet.

• Familiarity with data management and visualization tools (e.g., SharePoint, Teams, Power BI).

• Ability to create and maintain Gantt charts, dashboards, and tracking templates.

• Comfortable working within document management systems (e.g., Veeva Vault, eQMS, or similar).

Education Required:

• BS or higher in engineering and/or related discipline.

Travel:

• May require domestic travel up to 5% travel

BeOne Global Competencies:

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

• Fosters Teamwork

• Provides and Solicits Honest and Actionable Feedback

• Self-Awareness

• Acts Inclusively

• Demonstrates Initiative

• Entrepreneurial Mindset

• Continuous Learning

• Embraces Change

• Results-Oriented

• Analytical Thinking/Data Analysis

• Financial Excellence

• Communicates with Clarity

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.