Associate Director, External Manufacturing Operations

The External Manufacturing Operations Associate Director, is accountable for meeting customer demand at the Contract Manufactures (CMO's) they manage by achieving excellence in Compliance, Supply, Continuous Improvement & Cost through their leadership and coaching of the responsible cross functional teams and their work in partnership with those CMO’s while leveraging lean manufacturing principles and the end to end (E2E) supply chain.

The External Manufacturing Operations Associate Director supports the Focus Factory Lead and serves as a point of contact for dealings between our Manufacturing Division and the CMO and establishes a strong business partnership as well as boundaries and ground rules of engagement. External Manufacturing Operations Associate Director will assist in our relationship with the contract manufacturer to deliver commercial supply or project execution through technology transfers.

The individual will participate on a cross-functional team (Supply Chain, Quality, Technical Ops, Procurement…) who are responsible for delivering daily/weekly/monthly/annual requirements at their external partner(s).

Main responsibilities include but are not limited to:

• Ensures compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand; Dispute resolution (w/ appropriate escalation); Production Planning; Materials Management (SAP entries, Logistics); Technology issues; Oversight of shop floor production (determining when functional subject matter expertise should be deployed to the External Party’s (EP) facility); Lean Manufacturing and Continuous Improvement activities; Linking E2E (upstream and downstream) and with Supply Chain Management in the Supply Chain to ensure and optimize flow of materials.
• Is frequently present at their external partners site on the production floor, builds a strong interdependent relationship with the sites leadership team and is able to (“read a site”) assess & diagnose with appropriate tools and resource the true current condition & risks at a partners site and formulate in partnership with the external partner and our Company cross-functional team action orientated and time bound improvement plans.
• Partners with internal External Manufacturing team members including; Procurement, Quality, and Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required. The External Manufacturing Operations Associate Director may not be involved in all transactional interactions if they can be managed/delegated to a functional area but will be kept apprised of status/resolutions, etc.
• Participates in and represents External Manufacturing on the cross-functional teams with Supply Chain Management/Product Source Management/Procurement/Integrated Development and Supply Team for due diligence ahead of siting approval & post siting approval to support Sour of Supply (SOS)/New Product Introduction (NPI) changes at an external party and assume primary ownership of the new relationship.
• Ensures there is a plan with clear actions and timelines in place to delivery this SOS or NPI.
• Works with the external partner to understand CMO capacity (e.g. stated capacity, firm capacity, future capacity plans, time horizon / lead times required, comments/concerns, etc.) and future capacity based on agreed improvements.
• Is accountable for maintaining the integrity of the Master Supply Agreement ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control and for ensuring contract terms agreed upon by our Manufacturing Division and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments.
• Is accountable for inventory control. Depending on the location of goods (at External Party or at our Company), External Manufacturing Operations Associate Director ensures adequate documentation of material disposition. In some markets, External Manufacturing Operations may need to witness the destruction of goods (to prevent counterfeiting) or have the External Party certify the destruction, per destruction procedures.
• Acts as our Company continuous improvement system leader & coach for own team and works with external partner and lean manufacturing resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved.
• Supports the external partner periodic Business and Operations Review Meetings. Based on our Company and External Manufacturing strategy the External Manufacturing Operations Associate Director develops with their cross functional team and their external partner the annual plan for the relationship with clear goals and targets.
• Prepares an annual “state of the union” presentation for the relationships she or he manages which includes successes and failures in order to leverage across External Manufacturing Organization.
• Participates in the creation and maintenance of an External Manufacturing Organization Handbook containing Global External Manufacturing policies, procedures, templates, etc.

Qualifications:

• Bachelor’s degree preferably in the Engineering, Science or Business and a minimum 8 years’ experience in commercial /business and manufacturing (biologics operations, quality, technology, planning), roles required with a significant portion in management/leadership positions.
• At least two (2) years of experience in management/leadership positions.
• Has experience and ability to achieve compliance goals, through a risk-based approach has a deep understanding of GMP and EHS compliance and compliance risk in Biologics Operations.
• Has proven Lean Six Sigma skills to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.
• Has skills to understand and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.
• 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.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Who we are

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.