Associate Director, External Manufacturing

Merck & Co. • West Point, PA

388d • Onsite

About The Position

The Associate Director, External Manufacturing plays a crucial role in managing relationships with Contract Manufacturing Organizations (CMOs) to ensure operational efficiency, compliance with regulatory standards, and financial stewardship. This position involves strategic partnership and operational leadership to drive business performance and mitigate risks associated with manufacturing processes.

Requirements

• Bachelor's degree in Engineering, Science, or Business.
• Eight years of experience in commercial/business and manufacturing roles, including biologics, operations, quality, technology, or planning.
• At least two years of experience in management/leadership positions.
• Experience achieving 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 quality, cost, and lead-time objectives.
• Excellent financial stewardship skills.
• Strong interpersonal, communication, collaboration, and negotiation skills.
• Ability to apply understanding of end-to-end supply chain to achieve results.

Nice To Haves

• Direct Health Authority Audit experience is desirable.

Responsibilities

• Establishes and maintains a strong business partnership with assigned CMO.
• Generates, submits, and controls the financial budget for the CMO.
• Prepares and 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 on contractual aspects of the relationship.
• Creates or releases purchase orders and approves invoices.
• Leads dispute resolution with the CMO and escalates issues as necessary.
• Proactively drives risk assessments and manages risks with the CMO.
• Defines risk mitigation actions and updates relevant risk management systems.
• Represents External Manufacturing Operations in internal product team meetings.
• Collaborates with Quality, Supply Chain, and Logistics to ensure material flow between manufacturing nodes.
• Accountable for inventory control and documentation of material disposition/destruction.

Benefits

• Health insurance coverage
• Dental insurance coverage
• 401k benefit for retirement savings plan
• Flexible scheduling options
• Paid holidays
• Professional development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees