Merck Associate Director, External Manufacturing Operations in Millsboro, Delaware
Position Overview - Basic Functions & Responsibility:
External Manufacturing Operations Associate Director (Ops AD), in partnership with the respective functional representatives, is responsible for ensuring the reliable supply of quality products at competitive costs from external manufacturing partners (EPs) and to integrating these EP into our company's supply chain appropriately. The MK-4482 Ops AD is the owner and primary point of contact for all interactions between our Manufacturing Division and the three newly sited EPs. S/he is responsible to establish boundaries and ground rules for engagement with the EPs, while ensuring compliance/quality readiness of these suppliers at all times through the implementation of risk assessments and frequent walkthroughs. The number of EPs an Ops AD is accountable for will depend upon factors such as: product type, size and/or complexity of supply agreement, geography, etc.; however Ops AD will typically manage relationships that are highly complex in nature and of strategic importance.
Primary Activities include but not limited to :
The new Ops AD will have responsibilities for the DP sites supporting the MK-4482 Oral antiviral agent being developed for the treatment of COVID-19. The new Ops AD will ensure readiness of these new sites for commercial launch of the product, and sustaining the functioning of the FFT teams overseeing the partners selected, which include all formulations sites and partnering with packaging sites FFT teams for packaging sites selected. The Ops AD shall be able to drive global competitiveness on cost and lead-time with 100% compliance for each of the EP s/he manages. The Ops AD shall serve as “Virtual Plant Manager” for the MK-4482 external partners to achieve in-depth understanding of the EPs’ systems, capabilities and capacity utilization, and to be actively engaged in the EPs’ operations to ensure reliability of our company's supply chain. The Ops AD is the primary owner of our Manufacturing Division's relationship with the EPs for the MK-4482 product and the point of contact for all interactions between the two parties. S/he shall serve as the air traffic controller for all information exchanges between our Manufacturing Division and EPs and shall establish boundaries and rules of engagement. The Ops AD is the leader of our company's ExM cross-functional (Tier 2) team assigned to each EP involved in the MK-4482 and ensures proper execution of the Tier management process. S/he may not be involved in all transactional interactions if they can be managed or delegated to a functional area but will be kept apprised of status/resolutions. The Ops AD shall proactively drive risk assessment across the whole value chain s/he is responsible for and shall work closely together with his/her tier team and EP to manage and mitigate risks to aim at zero interruption of the supply chain and to ensure 100% compliance in quality and in environment, health and safety. S/he will maintain routine communication with internal stakeholders via weekly updates through the “Tier” process to ensure prompt escalation of any emerging issues. The Ops AD will also represent his/her team at the weekly Control Tower meetings, a forum established to communicate and manage risks holistically throughout the portfolio of suppliers managed by ExM Operations. The Ops AD shall apply understanding of the end-to-end supply chain (i.e. design, plan, source, make and deliver), knowledge of cross-functional interdependencies within our Manufacturing Division and an understanding of the interactions with internal sites to achieve operational excellence. S/he shall use knowledge of operational processes to develop and execute programs and initiatives working together with EPs with sense of urgency to drive for mutually beneficial business results.
The Ops AD is responsible for all operational related activities and is the primary point of contact for:
Dispute resolution (w/ appropriate escalation)
Balancing our company's delivery requirements with contract manufacturer’s production plan. Materials Management (ERP transactions, Logistics)
Oversight of shop floor production (determining when an ExM functional rep should be deployed to the contract manufacturer’s facility)
Continuous Improvement activities
The Ops AD partners with Procurement in the Identification/Selection of new contract manufacturers and Negotiation/Termination of Supply Agreements, as required.
The Ops AD facilitates the collection of contract manufacturer’s capacity information (e.g. stated capacity, firm capacity, future capacity plans, time horizon / lead times required, comments/concerns, etc.), presents the information to Supply Chain Management and drives recommendations for capacity expansion at contract manufacturers, as required.
The Ops AD is responsible to ensuring alignment of the Supply and Quality agreements.
The Ops AD is responsible for executing ERP transactions associated with receipt and movement of company owned inventory, book-to-physical reconciling of company owned inventory at contract manufacturers, and documenting and witnessing destruction of company owned inventory.
The Ops AD is responsible for ensuring contract terms agreed upon by our company and the contract manufacturer including, but not limited to, purchase orders, forecasts, deliveries, and invoice payments are executed in compliance with the Supply Agreement.
The Ops AD partners with the ExM Company Production System experts and other functionalities supporting ExM (e.g. technical, quality, procurement, etc.) to identify continuous improvement opportunities at contract manufacturers and supports
The Ops AD may be involved in providing project management support to the DP NA regional team, and to ensure a greater coordination of ongoing projects within the region.
This position will require travel up to 50%.
Education Minimum Requirement:
- Bachelor’s degree minimum in the Engineering, Medical, Science, Business, or related areas of study.
Required Experience and Skills:
No less than seven (7) years combined experiences in commercial / business and manufacturing (operations, project management, or quality, technology, supply chain etc.) function in pharmaceutical, chemical or related industry required (or equivalent combination of education/experience).
Must possess excellent interpersonal, communication, project management, collaboration, negotiation, analytical and influencing skills.
Has demonstrated strong leadership in a teamwork environment and with strong team coordination abilities.
Cultural awareness and sensitivities
Fluency in English (both verbal and oral).
Preferred Experience and Skills
Recent prior experience in ExM Operations or site operations
Conversant on domestic and foreign regulations and compendia governing manufacturing operations
Experience in Lean project implementation
Strong influencing skills demonstrated at various levels
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.
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
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Flexible Work Arrangements:
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Number of Openings:
Requisition ID: R73224
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