Associate Director, External Manufacturing

Job Description

In collaboration with the External Manufacturing Focus Factory Lead, this role is integral to fostering and maintaining strong business relationships with our assigned Contract Manufacturing Organization (CMO). The position is responsible for managing the operational and financial aspects of the CMO relationship, driving business performance, and ensuring compliance with all regulatory and quality standards.

This important role involves a combination of strategic partnership, financial stewardship, and operational leadership to ensure the successful execution of manufacturing processes, risk mitigation, and the seamless flow of materials across manufacturing nodes. This position acts as the primary point of contact for all operational processes with the CMO, ensuring efficient, cost-effective, and compliant production in alignment with our company’s objectives and external supply chain goals.

Key Responsibilities:

• Establishes and maintains a strong business partnership, defines boundaries, ways of working and rules of engagement with assigned Contract Manufacturing Organization (CMO).
• Generates, submits, and controls the financial budget for the CMO.
• Prepares/maintains materials for internal and joint business review meetings.
• Acts as the primary point of contact for all operations business processes with the CMO
• Partners with the External Manufacturing team members including Procurement, Quality, Logistics and Technology on contractual aspects of the relationship, including amendments of the Product Schedule, scope changes, price updates, safety stock, raw material supply.
• Creates or releases purchase orders and approves invoices.
• Determines when functional subject matter expertise should be deployed to the External Party’s (EP) facility).
• Leads dispute resolution with the CMO and appropriate escalation within our company.
• Proactively drives risk assessments and works closely with the CMO to manage and mitigate risks to aim at launch readiness and compliance in quality and in environment, health, and safety. Defines risk mitigation actions. Is responsible to update relevant risk management systems to track CMO and program related risks and make them visible.
• Represents External Manufacturing Operations on internal product team meetings.
• Collaborates with Quality, Supply Chain, and Logistics to ensure flow of materials between upstream and downstream manufacturing nodes.
• Is accountable for inventory control and ensures adequate documentation of material disposition/destruction at the CMO.

Education Minimum Requirement and Experience:

• Bachelor’s degree in Engineering, Science, or Business with eight (8) years’ experience in commercial/business and manufacturing roles, including biologics, operations, quality, technology, or planning.

Required Skills and Experience:

• At least two (2) years of experience in management/leadership positions
• Experience and ability to achieve compliance goals through a risk-based approach with a deep understanding of GMP and EHS compliance in Biologics Operations.
• Proven Lean Six Sigma skills to deliver compliant supply and achieve highest quality, lowest cost, and shortest lead-time.
• Understand and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.
• Demonstration of excellent financial stewardship skills
• Can visualize the way forward, identifying opportunities that add value to the work and proactively mitigate risk across the value chain.
• Must possess excellent interpersonal, communication, collaboration, and negotiation skills to work outside boundaries as a norm.
• Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.
• Ability to apply understanding of end-to-end supply chain within external and internal network and stakeholders across the network to achieve results and contribute to supply chain optimization.
• Direct Health Authority Audit experience is desirable.

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Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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