Associate Director, Global Supplier Management, Critical Raw Materials

Company: Initial Therapeutics, Inc.
Location: San Carlos
Posted on: February 1, 2025

Job Description:

Join our Mission to Protect Humankind!Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:

• RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
• AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
• LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
• MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality, and clarity across communications and decision making.Summary:The Associate Director - Global Supplier Management, Critical Raw Materials will lead and coordinate supply chain responsibilities for cGMP manufacturing of critical raw materials used in the production of conjugate vaccines. In this role, the incumbent will serve as the business relationship lead and supply chain lead for selected critical raw materials CDMOs. This role will manage manufacturing sites at all stages of the product lifecycle - from initial technology transfer to commercial stage manufacturing.This position provides leadership to ensure that operations at selected CDMOs run smoothly, the project team is equipped with necessary resources, and that challenges are effectively communicated to internal and external stakeholders. The incumbent will work with the organization to ensure on-time execution and appropriate planning for commercial lifecycle management.This position will report to the Director of Global Supplier Management. The Associate Director - Global Supplier Management, Critical Raw Materials will collaborate on overall program strategy, with primary responsibility and accountability for the CDMO business relationship and coordination of input/output materials supply.Essential Functions:
• CDMO Management: Act as primary point of contact for business and supply chain relationship with vendors to facilitate smooth operations and assure the right material is in the right place at the right time.
• Business Logistics: Collect and integrate feedback on new proposals/change orders from Vaxcyte stakeholders including process development, analytical development, project management, QA, supply chain, MSAT, legal, and finance. Initiate purchase requisitions, shepherd approval, and track issuance to vendors. Manage work orders, purchase orders, and inventory receipts as needed in ERP. Track and confirm deliveries to release payment of invoices.
• Forecasting: Understand site capacity and delivery constraints including cycle time and yield. Work with internal supply planning team to develop manufacturing forecasts that meet both Vaxcyte and CDMO requirements. Assure time horizon of planning is adequate to enable project teams to react to changing forecasts and build increased capacity as necessary.
• Materials Supply: Work with CDMO to confirm site keeps adequate inventory of raw materials and consumables to manufacture forecasted deliverables without interruption. Identify long lead/high risk items and develop plans with CDMO to mitigate risks associated with supply interruptions or increased product demand. Identify areas of improvement and lead implementation of plans to address.
• Risk Identification: Use knowledge of GMP manufacturing and supply to identify general or specific project risks that could impact product delivery timing or quality. Rectify issues at team level or escalate as appropriate. Work with team to develop mitigation plans and present to leadership for approval. Monitor execution, implementation, and effectiveness.
• Process Optimization: Work with project team to periodically evaluate manufacturing process and identify areas of wastage, low yield, and cost savings opportunities. Drive implementation of optimizations to address identified areas of improvement.
• Performance Monitoring: Establish KPIs with vendors to track metrics assessing supplier performance (goals tracking, on-time delivery, yield, quality, etc.). Coordinate performance summaries at periodic Joint Steering Committee meetings.
• Tech-transfer: Help to identify new manufacturing sites and facilitate communication/organization of relationship establishment. Be comfortable working in low-structure environments, take initiative to identify and implement systems to transition to steady-state operations.
• Interface: Collaborate with cross-functional teams across the network, including Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering, to drive the successful development and commercial launch of critical raw materials for pipeline products.
• Communicate: Effectively and efficiently communicate process performance to key stakeholders (internal-facing and external-facing). Connect and build strong working relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.Requirements:
• B.S/ B.A. in Life Science or Supply Chain related discipline with a minimum of 10 years' experience working in pharmaceutical/biotech supplier management.
• Strong experience working directly with/for CDMOs.
• Strong knowledge of GMPs.
• Experience in building relationships with cross-functional project teams to drive manufacturing readiness and efficiency.
• Experience with large and small molecule manufacturing, chemical synthesis, scale-up, technology transfer, process qualification, and relevant manufacturing process technologies is preferred.
• Excellent organization, problem-solving, and strategic planning skills.
• Highly skilled in both verbal and written communication with the ability to interact effectively with people of diverse backgrounds and perspectives.
• Proactively recognizes needs and potential challenges and directs activities to implement effective solutions. Steps into gaps to move projects forward.
• The ability to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy.
• An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.Reports to: Director, CMC Supplier ManagementLocation: San Carlos, CACompensation:The compensation package will be competitive and includes comprehensive benefits and an equity component.Salary Range: $190,000 - $203,000 (SF Bay Area). Salary ranges for non-California locations may vary.Vaxcyte, Inc.825 Industrial Road, Suite 300San Carlos, CA 94070We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.#LI-JN1
  #J-18808-Ljbffr

Keywords: Initial Therapeutics, Inc., San Jose , Associate Director, Global Supplier Management, Critical Raw Materials, Executive , San Carlos, California