The General Manager, Biologics Manufacturing USA will be providing leadership for the Biologics Manufacturing site in Hopewell, NJ, USA.

This role will be responsible for overseeing all aspects of the biologics including mAb and ADC drug substance and drug product including small molecule OSD production, and label & packaging within the manufacturing facility including but not limited to strategic planning, operational management, quality assurance, regulatory compliance, budget (P&L) management, and management of the site leadership team and site employees with diverse background and experience. This will include being an active and contributing member of the Technical Operations Leadership Team working closely with senior management in all matters of strategy and execution and being a partner to enabling functions within BeiGene, including Global Technology Solutions, HR, Finance and Procurement.

Essential Functions of the job:

• Experienced in pharmaceutical cGMP manufacturing, possessing a deep understanding of regulatory requirements across US, EU, China, and other regions’ approvals.

• Accountable for biologics CMC, manufacturing facility development, and capacity expansion, overseeing production and quality operations while managing budgets and personnel effectively.

• Lead and manage extensive cross-functional teams with hands-on experience across critical areas including CMC, Clinical & Commercial Production, PD/MST, Quality Management, and Facility development and maintenance.

• Establish and monitor production strategies and performance metrics (KPIs) to optimize operational efficiency and meet organizational objectives.

• Develop long-range plans (LRP) and annual operating plan (AOP) budgets with Finance and Procurement, implementing controls to ensure alignment with cost, revenue, and profit parameters.

• Oversee and manage green-field projects from design to completion, including Architecture & Engineering and Construction Management partnerships, ensuring seamless execution and timely delivery.

• Develop and nurture relationships with key stakeholders such as government officials, vendors, and CMOs to support BeiGene’s R&D and commercialization endeavors.

• Provide leadership and coordination among business partners, functional groups, and manufacturing teams to ensure financial objectives are met and operational excellence is maintained.

• Effective communication with stakeholders at all levels, ensuring change management process and providing routine updates on site status.

• Provide strategic oversight to the industrialization efforts of BeiGene’s global biologics drug products, ensuring alignment with organizational objectives and regulatory approvals.

• Adhere to regulatory standard and corporate policies, maintaining compliance across all operational activities.

• Provide leadership to leverage external and internal benchmarking and standardization initiatives within the organization, fostering continuous improvement and operational excellence.

• Attract, develop, and retain top talents, fostering an inclusive environment that motivates diverse teams to achieve desired business results.

• Lead and coach team to drive high performance culture to accommodate rapid and dynamic growth with results in operational excellence and high employee engagement.

Supervisory Responsibilities:

• Yes

Computer Skills: PC, including MS Office Suite.

Skills and Qualifications:

• Bachelor’s or Master’s degree in a relevant engineering or technology field required

• Minimum of 20+ years of experience in pharmaceutical and/or biotech industry with a proven track record of accomplishments recognized by world-class experts

• Minimum of 14+ years of experience in a director-level role and above is required

• Proficient in building and leading extensive cross-functional teams with hands-on experience across critical areas including CMC, Clinical & Commercial Production, PD/MST, Quality Management, and Facility development and maintenance

• Thorough working knowledge of facilities, equipment, operations, and management practices

• Experience with developing and monitoring production strategies and performance metrics (KPIs)

• Excellent organizational, leadership, motivational, analytical problem solving and strategic thinking skills

• Proficiency in green-field projects and CAPEX management, as well as Change management

• Strong negotiation and management leadership skills

• Proven ability to cultivate strategic internal and external business partnerships, including with CMOs, vendors, and government officials where required

• Skilled in building cross-functional partnerships, engaging internal & external stakeholders, and leading cross-functional teams and initiatives

• Ability to discuss a wide range of topics from business strategy to the tactical execution of the strategy

• Excellent written and verbal communication skills

• Must be able to work in a fast-paced environment with dynamic priorities and demands

• Multi-lingual skills would be advantageous

Travel: As needed basis

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.