Director, Commercial Supply Chain Management

Position Summary:

The Director of Commercial Supply Management will provide direction and subject matter expertise in commercial supply management.  S/he will work with internal and external teams to develop biologics commercial supply chain strategy and ensure effectiveness of execution.  In accordance with Zenas’ outsourcing model for drug development, the incumbent will oversee the planning and execution of outsourced commercial supply chain activities and will work proactively with external partners to define project scope, mitigate risks, and ensure successful delivery as it relates to technical product quality, project timelines and budgets.  S/he will work within a cross-functional development team environment to support Zenas’ short-term, intermediate, and long-term strategic goals.

Key Responsibilities:

• Deliver an integrated commercial supply chain launch plan for a late-stage program, includes establishing safety stock for raw materials and finished products, CDMO operational readiness to successfully launch, capacity analysis and integration of system requirements and complicated cold chain logistics.
• Maintain commercial forecast and supply plan. Interact effectively and transparently with internal stakeholders in the areas of Commercial Operations, Sales/Marketing, Technical Operations, Quality Assurance, Regulatory Affairs, Strategic Sourcing and Vendor Management, and external business partners.
• Drive excellence in end-to-end operations through identification and management of key commercial supply chain KPI's.
• Drive operational efficiency and continuous improvement across the commercial supply chain to drive down COGs and deliver a best-in-class supply chain.
• Lead and manage all aspects of the commercial label/packaging activities at the CDMO.
• Support the 3PL strategy and development with the commercial organization.
• Support serialization activities.
• Develop and lead the Sales & Operations Planning process. Partner with Finance and Commercial Operations to deliver a plan including balancing forecast scenarios, risk and budget impact.
• Contribute to the development and design of the ERP and serialization systems by providing the user input and contributing to testing that complies with FDA Drug Supply Chain Security Act.
• Develops and maintains a robust commercial inventory management system.
• Budget/scope management related to commercial supply chain.
• Pro-actively collaborate with internal stakeholders and external business partners to achieve group, departmental and corporate goals. Support business partner obligations.
• Provide clear communication to the management team regarding progress against technical objectives/milestones.
• Ensure well-organized, clear, and complete records of all activities across areas of responsibility.
• Develop and maintain SOPs, policies, and guidance documents relevant to areas of responsibility.
• Manage and execute personnel qualification/training program.

Qualifications:

• BS/BA in science or engineering or a related field with a minimum of 10 years experience; hands-on working experience in commercial supply chain management in the biopharmaceutical industry is required. Advanced degree preferred.
• Must have hands-on working experience in ERP and serialization systems and setting up MRP systems.
• Must have experience managing commercial forecasts with CDMOs and developing commercial supply plans.
• Must have experience working with CDMOs for commercial labeling/packaging as well as distribution strategies with 3PLs.
• Experience in supporting commercial launches, validation plans and IQ/OQ
• Experience developing and leading S&OP meetings.
• Experience writing commercial supply chain management SOPs and guidance’s.
• Experience with drafting RFPs and ability to negotiate and select commercial labeling/packaging vendors.
• Familiar with current regulatory requirements (FDA, EMA, ISO) related to biologics commercial labeling/packaging.
• Highly organized, exceptional attention to detail, and strong proficiency in documentation skills.
• Strong communication and follow-up skills
• Must work well in a small team setting, with the ability to work independently and collaboratively.
• Demonstrated ability to facilitate project team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders.
• Ability to work flexible business hours to communicate with global business partners (up to 20% of the time)

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Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $170,400 to $213,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.