Senior Manager, Supply Chain - CMO Management & Project Management
BeiGene
Summary
The Senior Manager, Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the contract manufacturers (CMO) and the functions within the company to meet contract's deliverables, provide services, and keep the relationship positive & on track and deliver performance goals. He/she will also work with functions within the company to support and/or lead new product introduction, new market launches as necessary. This role will be focused on process improvement and change management to ensure cross functional alignment in supporting successful tech transfers, qualifications at CMOs.
Job description
Responsibilities (including but not limited to):
The position is responsible for managing all aspects of global Contract Manufacturing partnerships, driving productivity through strategic initiatives with Contract Manufacturers (CMO).
- In partnership with Quality, CMC, Procurement, ensures that innovation, manufacturing performance, cost objectives and quality goals are met or exceeded at CMOs
- The role requires strong manufacturing and operational knowledge in the pharmaceutical industry and ability to collaborate and influence in cross functional areas internally and externally
- Manage and direct the business relationship with contract manufacturers, navigating issues and negotiating solutions to ensure efficient and cost-effective production & continuity of supply
- Partner with internal stakeholders such as CMC, GTO, RA to ensure that on time commercial launch & new market launch of products according to the company's commercialization, quality, safety, regulatory compliance requirements, and contractual commitments with CMOs
- Develop and maintain CMO management governance structure, communication matrix, standard templates ("playbook") to properly address supply chain and quality issues with timely root cause and corrective actions, develop short & long-term mitigation plan for supply stability from CMOs
- Coordinate with Procurement, Quality, and other internal departments to cross-functionally resolve elevated issues
- Develop & maintain KPIs for CMO
- Oversee monthly actual-to-budget cost variances, identify root cause and drive cost improvements
- Promote and drive contract manufacturing production efficiency
- Support Procurement to negotiate CMO contracts, amendments, and renewals, aligning with the 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 along with other key functions (Commercial, S&OP, Manufacturing, SC Planning, Logistics, Quality, MDM, and commercial Artwork services) and track progress for on-time launch
- Key business partner in the project core team monitoring key milestone progress against the plan and communicating achievements or deviations to launch plans
- Ensure that identified continuous improvement opportunities in the overall launch processes. Work closely with key business partners in Tech Ops, Regulatory; Supply Chain; Commercial; Quality to establish clear processes and deliverables.
- Reports milestones per plan in a consistent manner to meet the Launch objectives and metrics
- Monitors project execution and adjust plans. Facilitates project communications and documentation
- Collaborates with the team to resolve issues and organizes team to execute on the corrective actions
- Ensures project work complies with established practices, policies, and processes
- Assist in the creation of Standard Operating Procedures
- Interface with all levels of management
Computer Skills
In-depth knowledge and skill with Microsoft Project, Excel, PowerPoint, Word, Visio and other reporting/tracking tools.
Other Qualifications
Due to global nature of company early morning or evening meeting may be required. Travel: 20%.
Education Required
- Bachelor's degree is required in a scientific field
- 7+ years' experience within biopharmaceutical/pharmaceutical CMC development, GMP and regulatory requirements
Requirements
- Bachelor's degree in a scientific field
- 7+ years' experience within biopharmaceutical/pharmaceutical CMC development, GMP and regulatory requirements
- Strong manufacturing and operational knowledge in the pharmaceutical industry
- In-depth knowledge and skill with Microsoft Project, Excel, PowerPoint, Word, Visio and other reporting/tracking tools
- Ability to collaborate and influence in cross functional areas internally and externally
- Willingness to travel 20%
- Ability to accommodate early morning or evening meetings due to global nature of company
Benefits
- Medical, Dental & Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
- Annual bonus plan
- Discretionary equity awards
- Employee Stock Purchase Plan
Company overview
BeiGene, Ltd., now rebranding as BeOne Medicines, is a global commercial-stage biotechnology company specializing in the discovery, development, manufacturing, and commercialization of innovative oncology medicines. Founded in 2010 by John V. Oyler and Xiaodong Wang, the company has grown into a multinational organization with headquarters in Cambridge, Massachusetts, Beijing, China, and Basel, Switzerland. BeiGene focuses on developing targeted and immune-oncology therapies for cancer treatment, with a diverse pipeline that includes internally discovered products like BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase inhibitor, and Tevimbra (tislelizumab), a PD-1 inhibitor. The company operates across six continents with over 45 countries participating in clinical trials and has enrolled more than 30,000 patients in its research programs. With approximately 12,000 employees worldwide, BeiGene has established itself as a significant player in global oncology, particularly with strong market presence in China and expanding operations in the United States and Europe. The company's mission centers on expanding access to high-quality cancer therapies worldwide through persistent innovation and challenging traditional approaches to drug development.