at Merck in Millsboro, Delaware, United States
New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.
Our Company is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division. The Associate Director, External Manufacturing Operations is responsible for leading an integrated cross-functional team in oversight of commercialization activities with External Partners that manufacture, assemble, and test complex device components and delivery systems required for new pharmaceutical and biological products.
Our team works with a “Safety First, Quality Always” mindset. As the primary point of contact between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong relationship with External Partners and ensuring excellence in compliance, supply, continuous improvement, and cost management. As we continue to drive growth in this area of our business, this role will also collaborate with a wide range of professional disciplines in Research, Manufacturing, and Commercial Operations.
Primary Responsibilities and Activities include but are not limited to:
Supplier Onboarding and Risk Mitigation:
Assess supplier capabilities, capacity, and manufacturing processes. Work with External Partner to execute plans to close any gaps.
Evaluate business case for facility and/or equipment investments.
Provide Operations input into key Agreements (Development, Supply and Quality).
Ensure External Partner Site Readiness for Phase III Supply, Validation, Technology Transfer and Commercial Launch.
Establish a “Right-First-Time” culture. Presence on the production floor at External Partner site(s) as required.
Project Management – Leverage standard project management tools to plan, communicate, execute, and track deliverables and risk management activities.
Factory Support – Manage operational risks and activities. Resolve Quality and Technical Issues (including Investigations, CAPAs, Source Changes, Equipment Maintenance / Reliability).
Supply Chain Management: Work with External Partners and receiving supply nodes to deliver On-Time and In-Full, optimize flow of materials, de-risk Tier 1 and Tier 2 supply chains, and ensure appropriate Demand Management, Production Planning, Inventory Management, and Logistics.
Compliance: Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation and Complaint Management, Change Control). Work with Quality teams to ensure robust Quality Management System and maintain adherence to terms in the Quality Agreement.
Financial Stewardship : Maintain adherence to terms in the Supply Agreement. Provide input into Operations Profit Planning processes. Manage Budget, Estimated Actuals, and Accruals for projected spend (Expense, Capital/Prepaid, and Product Cost).
Continuous Improvement: Establish baseline KPI and trends as leading indicators of supplier performance at launch and throughout product lifecycle. Ongoing assessment of risks at External Partner site(s) using appropriate tools and resources. Formulate actionable and time bound improvement plans.
Relationship Management : Lead periodic Business Review Meetings (with External Partner and our company’s Leadership).
Governance and Conflict Resolution : Build interdependent relationship with External Partner Site(s) and Plant Leadership team(s) to manage issues. Escalate disputes within internal and external leadership team(s) and/or Joint Steering Committees as appropriate.
Minimum Education Requirement:
Bachelor’s Degree required. Degree in Engineering or Science strongly preferred.
REQUIRED Experience and Skills:
No less than eight (8) years of experience in Biopharmaceutical industry across multiple disciplines (Operations, Quality, Technology, Engineering, Supply Chain Planning, Sourcing, etc.). At least five (5) years leading teams and/or projects. At least two (2) years in direct management of shop floor production activities.
New Product Commercialization – Knowledge of Pharmaceutical product development milestones and commercialization process. Knowledge of unique requirements for Combination Product development and commercialization is a plus.
Project Management – Proficient with Project Management and Virtual Collaboration Tools (Microsoft Project, OneNote, Teams, SharePoint, Action Trackers, Risk Trackers, Decision Logs, etc.).
Supplier Relationship Management – Ability to manage supplier relationships across a spectrum of strategic priorities. Ability to influence stakeholders at all levels in organization.
Communication – Excellent communication and presentation skills (written and verbal). Ability to effectively influence key stakeholder groups (including senior and executive levels of an organization).
Stewardship of Company Intellectual Property – Ability to assess appropriate level of information disclosure and maintain confidentiality when dealing with multiple internal and external stakeholders.
Business & Financial Acumen – Ability to forecast and manage operating budgets (Expense, Capital/Prepaid, and Product Cost). Understanding of industry and economic data to make business decisions that drive value for our Company and our customers.
Compliance – Deep understanding of Good Manufacturing Practices (GMP) and Environment & Safety Regulations.
Strategic Thinking – Ability to identify opportunities that add value to the work – proactively mitigating risk across the value chain.
Working Across Boundaries – Excellent interpersonal and networking skills. Demonstrated ability to build relationships and collaborate with internal and external partners as the normal way of working.
Inclusion – Create and maintain an inclusive culture and high-performing team (coaching team members as required).
Drive Results and Business Outcomes – Ability to use deep knowledge and expertise in Manufacturing, Technical, and Quality Operations to drive results and business outcomes.
End-to-End Mindset – Demonstrated ability to apply understanding of end-to-end requirements (within external and internal network) to achieve results and optimize supply chain.
International Experience – Ability to effectively engage and collaborate with diverse cultures across the globe.
PREFERRED Experience and Skills:
Medical Device Manufacturing Knowledge – Expertise in Injection Molding and Automated Assembly processes, equipment, and best practices. Experience with Final Assembly and Packaging of Combination Products. Experience with OEB 4 / OEB 5 compounds is a plus.
Strategic Sourcing and Contract Negotiation – Knowledge of device suppliers and marketplace dynamics. Experience negotiating complex agreements with Freedom to Operate risks is a plus.
Process Improvement – Knowledge of lean principles, equipment design, and preventative maintenance.
MDCP Regulations – Awareness of global regulations and compliance requirements governing development and manufacturing for Medical Devices & Combination Products (21 CFR Part 4, Medical Device Reporting, ISO 13485:2016, EU Medical Device Regulation).
Digital Solutions – Awareness of connectivity and software validation requirements is a plus.
Our Manufacturing Division is committed to be the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network tha