Director, Small Molecule, Manufacturing Sciences and Technology

BeOne is seeking a highly motivated, collaborative professional with a passion for fighting cancer to join our Manufacturing Science and Technology (MST) department. This role supports BeOne’s Small Molecule Manufacturing Plant, currently in the design phase, serving as the site Subject Matter Expert (SME) for Oral Solid Dose (OSD) manufacturing. The position provides technical leadership for facility design, equipment selection, start-up activities, technology transfer, lifecycle validation, and technical support for commercial manufacturing. This onsite role is based at BeOne’s U.S. Manufacturing Site in Hopewell, NJ and reports to the Sr. Director of MST.

Responsibilities

• Serve as the site Subject Matter Expert (SME) for Oral Solid Dose (OSD) manufacturing processes, including wet granulation, drying, blending, tablet compression, and coating.
• Provide expertise in API manufacturing processes and specifications.
• Author technology transfer plans, validation protocols/reports, Comparability Studies, and regulatory filing documents.
• Leverage regulatory Health Authority experience, including inspections and regulatory submissions/correspondence.
• Investigate root causes of major deviations in cGMP manufacturing and implement CAPA (Corrective and Preventive Actions).
• Collaborate with Process Development, Process Sciences, Manufacturing, Quality, and CMC Project Management to facilitate technology transfer and project success.
• Lead late-stage/commercial Drug Product technology transfer, process characterization, and process validation.
• Apply working knowledge of GMP and regulatory requirements for biopharmaceutical manufacturing.
• Troubleshoot complex technical issues, compile, analyze, and interpret data, and prepare routine reports and correspondence.
• Hire, train, and develop a technical team to support facility start-up, technology transfer, and commercial pharmaceutical manufacturing.
• Build departmental processes and procedures for lifecycle validation and technical support.
• Lead cross-functional collaboration with Manufacturing Operations, Quality Assurance/Control (QA/QC), Facilities and Engineering (F&E), and Regulatory Compliance/Regulatory Affairs.
• Drive project leadership in fast-paced, complex environments with tight time and cost controls.
• Lead complex investigations, root cause analysis, and implementation of corrective actions.
• Establish a data and metrics-driven culture, maintaining alignment with global manufacturing sites through shared knowledge and solutions.
• Collaborate with Global CMC, MS&T, and Technical Development to enable new Drug Product manufacturing capabilities at the Hopewell location.

Requirements

• Bachelor’s degree and 10+ years of pharmaceutical industry experience required; Master’s degree and 7+ years of experience preferred.
• 7+ years of managerial experience directly managing people and/or leading teams, projects, or programs.
• Experience in technology transfer leadership for new product introduction or commercial lifecycle products.
• Life cycle validation leadership, including Process Design, Process Qualification, and Continued Process Verification.
• Strong PC literacy with MS Office skills (Outlook, Word, Excel, PowerPoint).
• Statistical software application experience preferred (JMP, Minitab, etc.).
• Six Sigma Green/Black Belt preferred.
• Up to 10% global travel required.

Skills

• Excellent troubleshooting and problem-solving skills.
• Strong interpersonal, verbal, and written communication skills, including the ability to present effectively to groups.
• Ability to work independently and collaboratively in a fast-paced, dynamic team environment.
• Ability to balance and prioritize multiple projects.
• Demonstrated ability to foster teamwork, provide and solicit actionable feedback, and act inclusively.
• Entrepreneurial mindset, continuous learning, adaptability to change, and results-oriented approach.
• Analytical thinking, data analysis, and financial excellence.

Pay

Salary range: $174,900.00 - $234,900.00 annually. Actual compensation is determined by job-related skills, depth of experience, certifications, relevant education or training, and specific work location.

Benefits

• Annual bonus plan (non-commercial roles) or incentive compensation plan (commercial roles).
• Discretionary equity awards and voluntary participation in the Employee Stock Purchase Plan.
• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs.