BeiGene - San Mateo, CA

posted 5 months ago

Full-time - Mid Level
San Mateo, 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 driving performance goals and will be instrumental in supporting new product introductions and market launches as needed. A significant aspect of this role involves process improvement and change management to ensure that all functions are aligned in supporting successful technology transfers and qualifications at CMOs. The responsibilities of this position encompass managing all aspects of global Contract Manufacturing partnerships, with a strong emphasis on driving productivity through strategic initiatives. The Sr. Manager/Associate Director will collaborate closely with Quality, CMC, and Procurement to ensure that innovation, manufacturing performance, cost objectives, and quality goals are consistently met or exceeded at CMOs. This role requires a deep 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. In addition to managing the business relationship with contract manufacturers, the individual will navigate issues and negotiate solutions to ensure efficient and cost-effective production while maintaining continuity of supply. The role also involves partnering with internal stakeholders to ensure timely commercial launches and new market introductions, adhering to the company's commercialization, quality, safety, and regulatory compliance requirements. The Sr. Manager/Associate Director will develop and maintain a governance structure for CMO management, including communication matrices and standard templates to address supply chain and quality issues effectively. Furthermore, the position entails overseeing the development of key performance indicators (KPIs) for CMOs, managing budget variances, and driving cost improvements. The individual will support procurement efforts in negotiating contracts and amendments with CMOs, aligning these with business strategies. Project management of multiple complex project teams will be a critical component of this role, ensuring that new product and market launch activities are tracked and executed in collaboration with key functions such as Commercial, S&OP, Manufacturing, and Quality. The Sr. Manager/Associate Director will also be responsible for monitoring project execution, facilitating communications, and ensuring compliance with established practices and policies.

Responsibilities

  • Manage all aspects of global Contract Manufacturing partnerships.
  • Drive 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.
  • Manage and direct the business relationship with contract manufacturers, navigating issues and negotiating solutions.
  • Partner with internal stakeholders to ensure on-time commercial launch and new market launch of products.
  • Develop and maintain CMO management governance structure and communication matrix.
  • Coordinate with Procurement, Quality, and other internal departments to resolve elevated issues.
  • Develop and maintain KPIs for CMO.
  • Oversee monthly actual-to-budget cost variances and drive cost improvements.
  • Promote and drive contract manufacturing production efficiency.
  • Support Procurement in negotiating CMO contracts, amendments, and renewals.
  • Project management of multiple complex project teams for commercial and operational excellence.
  • Manage new product and new market launch activities related to supply chain.
  • Monitor key milestone progress against the plan and communicate achievements or deviations.
  • Ensure continuous improvement opportunities in the overall launch processes.
  • Report milestones per plan to meet launch objectives and metrics.
  • Monitor project execution and adjust plans as necessary.
  • Collaborate with the team to resolve issues and execute corrective actions.

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 high workload.
  • Strong communication skills, both written and verbal, 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.
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