Sr. Manager/Associate Director, Supply Chain - CMO Management & Project Management

BeiGene - Emeryville, CA

Full-time - Manager

Emeryville, CA

Chemical Manufacturing

About the position

The Sr. Manager/Associate Director, Supply Chain CMO Management & PM will play a pivotal role in overseeing and facilitating communication between contract manufacturers (CMOs) and various internal functions within the company. This position is essential for ensuring that contract deliverables are met, services are provided efficiently, and relationships with CMOs remain positive and productive. The individual in this role will focus on process improvement and change management, ensuring that there is cross-functional alignment to support successful technology transfers and qualifications at CMOs. In this capacity, the Sr. Manager/Associate Director will manage all aspects of global Contract Manufacturing partnerships, driving productivity through strategic initiatives. This includes collaborating with Quality, CMC, and Procurement to ensure that innovation, manufacturing performance, cost objectives, and quality goals are not only met but exceeded. The role demands a strong understanding of manufacturing and operational processes within the pharmaceutical industry, as well as the ability to influence and collaborate across various functional areas both internally and externally. The responsibilities extend to managing the business relationship with contract manufacturers, addressing issues, and negotiating solutions to ensure efficient and cost-effective production while maintaining continuity of supply. The individual will partner with internal stakeholders to ensure timely commercial launches and new market introductions, adhering to the company's commercialization, quality, safety, and regulatory compliance requirements. Additionally, the role involves developing and maintaining a governance structure for CMO management, including communication matrices and standard templates to address supply chain and quality issues effectively. The Sr. Manager/Associate Director will also oversee the development of key performance indicators (KPIs) for CMOs, manage budget variances, and drive cost improvements. This position requires project management skills to handle multiple complex project teams, ensuring that new product and market launch activities are tracked and executed on time. The individual will report on milestone progress, monitor project execution, and facilitate communications to ensure compliance with established practices and policies. Overall, this role is critical for driving operational excellence and ensuring successful product launches in a highly regulated environment.

Responsibilities

• Manage all aspects of global Contract Manufacturing partnerships, driving productivity through strategic initiatives with Contract Manufacturers (CMO).
• Ensure that innovation, manufacturing performance, cost objectives, and quality goals are met or exceeded at CMOs in partnership with Quality, CMC, and Procurement.
• Direct the business relationship with contract manufacturers, navigating issues and negotiating solutions for efficient production and continuity of supply.
• Partner with internal stakeholders to ensure on-time commercial launch and new market launch of products according to commercialization, quality, safety, and regulatory compliance requirements.
• Develop and maintain CMO management governance structure, communication matrix, and standard templates to address supply chain and quality issues.
• Coordinate with Procurement, Quality, and other internal departments to resolve elevated issues cross-functionally.
• Develop and maintain KPIs for CMO performance.
• Oversee monthly actual-to-budget cost variances, identify root causes, and drive cost improvements.
• Promote and drive contract manufacturing production efficiency.
• Support Procurement in negotiating CMO contracts, amendments, and renewals, aligning with business strategies.
• Project management of multiple complex project teams for commercial and operational excellence.
• Manage new product and new market launch activities related to supply chain and track progress for on-time launch.
• Monitor key milestone progress against the plan and communicate achievements or deviations to launch plans.
• Ensure continuous improvement opportunities are identified in the overall launch processes.
• Report milestones per plan consistently to meet launch objectives and metrics.
• Monitor project execution and adjust plans as necessary, facilitating project communications and documentation.
• Collaborate with the team to resolve issues and organize corrective actions.
• Ensure project work complies with established practices, policies, and processes.
• Assist in the creation of Standard Operating Procedures.
• Interface with all levels of management.

Requirements

• Experience in pharmaceutical project management.
• Strong experience in Project Management Office (PMO) processes, creating templates, and training materials.
• Excellent organizational skills, capable of setting priorities and managing a high workload.
• Strong written and verbal communication skills, including oral presentation skills.
• Ability to interact with multiple layers of the organization and influence at all levels.
• Understanding of comprehensive global pharmaceutical regulatory requirements (e.g., GMP, GDP).
• Strong analytical, problem-solving, and communication skills.
• Strong collaboration and excellent team skills to succeed in cross-functional and multi-cultural teams.

Nice-to-haves

• In-depth knowledge and skill with Microsoft Project, Excel, PowerPoint, Word, Visio, and other reporting/tracking tools.