Director, External Manufacturing Operations
MSD Malaysia, Rahway, NJ, United States
* The candidate leads an organization with direct oversight of the relationship with the CMO.
The role serves as the air traffic controller of all information / interactions between the Company and the CMO, establishes boundaries and rules of engagement, focusing on building the strength of the internal / external partnership, issue escalation of any type, and develops recommendations.* Represents External Manufacturing operations on the cross-functional teams with DCT, VCM, S&T, VCM, and Procurement and others to enable stand-up and delivery transfers of the pipeline programs.* The candidate is accountable for all operational related activities:* Compliance (Quality Risk management, Deviation Management, Product Release, Change Control).* Meeting Demand, Dispute Resolution (with appropriate escalation)* Production Planning & Materials Management (system data entries, Logistics)* Technology Issues* Oversight of shop floor production (assessing when an ExM functional lead should be deployed to the EP’s facility)* Operational Excellence and Continuous Improvement activities* Linking end-to-end Supply Chain nodes to ensure and optimize flow of materials* Responsible for Financial planning through active participation in the annual budget development process* Builds a strong interdependent relationship with the EP, facilitates and engages directly with site leadership teams with a capability to "read a site" and anticipate both areas of risk and areas of opportunity, fostering an interdependent relationship based on high degrees of collaboration.* Steers issue escalation though a formal “Tier” process* Partners with Procurement, Quality, Technology and Supply Chain on commercial aspects of the relationship, including recommendations associated with any part of the relationship lifecycle and strategic considerations associated with the company’s Manufacturing and Supply Network evolution (Identify, Select, Negotiate, Develop, Terminate), as required.* Develops an integrated view of capacity across the external partner network, escalates risk, develops recommendations, and guides execution of mitigation actions.* Is accountable for maintaining the integrity of the Master Supply Agreements ensuring alignment with the Supply and Quality agreements, appropriate document revision and distribution control.
Further ensures that the agreed-upon contractual terms are executed including purchase orders, forecasts, deliveries, and approving invoice payments.* Acts as our company's Production System (MPS) leader & coach for our internal Focus Factory Teams and direct reports.
Works with EP and our MPS resources, as needed, to identify operational excellence/ continuous improvement opportunities and supports implementation once approved. The ExM Operations Lead may commit resources provided the company and the EP would share in the costs and benefits of such operational improvements.* Drives the development of an Integrated Risk Management program across the EP Network inclusive of risk assessments, prioritization, and mitigation planning.* Contributes to the development of the External Manufacturing Network Strategy and drives strategic initiatives as an outcome.* Plans strategically and understands the broad EP business environment and specific opportunities & potential partners in their operations area.* Drives boundaryless collaboration, influence and connectivity by working directly with key internal stakeholders across all levels of management.* Leads special projects and assignments as needed* Bachelor’s degree minimum in the Engineering or Science preferred* Minimum ten (10) years' experience in small molecule drug substance and/or drug product manufacturing (operations, quality, or technology).* Compliance – Has experience and ability to achieve GMP and EHS compliance goals, through a risk-based approach across Drug Substance and/or Drug Product* Operational Excellence– Has proven Lean Six Sigma skills to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.* Depth of Manufacturing Knowledge – Has proven skills and expertise at management level drug substance and drug product platforms.* New Product Introduction & Technical Transfer – Has proven record, skills and expertise in planning and executing complex, multi-site technical transfers* Demonstrated experience in management/leadership positions.* Demonstrated experience in managing a complex portfolio of projects.* Business & Financial Acumen – Has skills to understands and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.* Candidate must be accomplishment oriented (self-motivated and persistent), possess a "business owner" mentality, possess the ability to influence without authority, and demonstrate the ability to effectively operate in an ambiguous/changing environment.* Ability to work in ambiguous situations, formulate a plan, focus on what matters, drive outcomes, and speak up and be open-minded.
Ability to prioritize conflicting demands, act with urgency, when necessary, effective follow-ups on tasks and activities.* Innovative thinking to experiment, learn and adapt new ways of working and initiatives supporting the strategy.* Influence - Using effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.* Networking & Partnerships - Building partnerships; developing and leveraging relationships within and across internal and external teams* Effective problem-solving and analytical skills, successfully navigating matrixed organizations, building consensus and influencing decision-making.* Strong communication skills to effectively engage with senior management and across all levels of the business.* Collaborative nature, with the ability to work with diverse personalities and collaborate effectively with various functions and stakeholders.* Strategic Planning - Prioritizing and planning; establishing an action plan for self and others to complete work efficiently and on time by setting priorities, establishing timelines and leveraging resources.**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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The role serves as the air traffic controller of all information / interactions between the Company and the CMO, establishes boundaries and rules of engagement, focusing on building the strength of the internal / external partnership, issue escalation of any type, and develops recommendations.* Represents External Manufacturing operations on the cross-functional teams with DCT, VCM, S&T, VCM, and Procurement and others to enable stand-up and delivery transfers of the pipeline programs.* The candidate is accountable for all operational related activities:* Compliance (Quality Risk management, Deviation Management, Product Release, Change Control).* Meeting Demand, Dispute Resolution (with appropriate escalation)* Production Planning & Materials Management (system data entries, Logistics)* Technology Issues* Oversight of shop floor production (assessing when an ExM functional lead should be deployed to the EP’s facility)* Operational Excellence and Continuous Improvement activities* Linking end-to-end Supply Chain nodes to ensure and optimize flow of materials* Responsible for Financial planning through active participation in the annual budget development process* Builds a strong interdependent relationship with the EP, facilitates and engages directly with site leadership teams with a capability to "read a site" and anticipate both areas of risk and areas of opportunity, fostering an interdependent relationship based on high degrees of collaboration.* Steers issue escalation though a formal “Tier” process* Partners with Procurement, Quality, Technology and Supply Chain on commercial aspects of the relationship, including recommendations associated with any part of the relationship lifecycle and strategic considerations associated with the company’s Manufacturing and Supply Network evolution (Identify, Select, Negotiate, Develop, Terminate), as required.* Develops an integrated view of capacity across the external partner network, escalates risk, develops recommendations, and guides execution of mitigation actions.* Is accountable for maintaining the integrity of the Master Supply Agreements ensuring alignment with the Supply and Quality agreements, appropriate document revision and distribution control.
Further ensures that the agreed-upon contractual terms are executed including purchase orders, forecasts, deliveries, and approving invoice payments.* Acts as our company's Production System (MPS) leader & coach for our internal Focus Factory Teams and direct reports.
Works with EP and our MPS resources, as needed, to identify operational excellence/ continuous improvement opportunities and supports implementation once approved. The ExM Operations Lead may commit resources provided the company and the EP would share in the costs and benefits of such operational improvements.* Drives the development of an Integrated Risk Management program across the EP Network inclusive of risk assessments, prioritization, and mitigation planning.* Contributes to the development of the External Manufacturing Network Strategy and drives strategic initiatives as an outcome.* Plans strategically and understands the broad EP business environment and specific opportunities & potential partners in their operations area.* Drives boundaryless collaboration, influence and connectivity by working directly with key internal stakeholders across all levels of management.* Leads special projects and assignments as needed* Bachelor’s degree minimum in the Engineering or Science preferred* Minimum ten (10) years' experience in small molecule drug substance and/or drug product manufacturing (operations, quality, or technology).* Compliance – Has experience and ability to achieve GMP and EHS compliance goals, through a risk-based approach across Drug Substance and/or Drug Product* Operational Excellence– Has proven Lean Six Sigma skills to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.* Depth of Manufacturing Knowledge – Has proven skills and expertise at management level drug substance and drug product platforms.* New Product Introduction & Technical Transfer – Has proven record, skills and expertise in planning and executing complex, multi-site technical transfers* Demonstrated experience in management/leadership positions.* Demonstrated experience in managing a complex portfolio of projects.* Business & Financial Acumen – Has skills to understands and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.* Candidate must be accomplishment oriented (self-motivated and persistent), possess a "business owner" mentality, possess the ability to influence without authority, and demonstrate the ability to effectively operate in an ambiguous/changing environment.* Ability to work in ambiguous situations, formulate a plan, focus on what matters, drive outcomes, and speak up and be open-minded.
Ability to prioritize conflicting demands, act with urgency, when necessary, effective follow-ups on tasks and activities.* Innovative thinking to experiment, learn and adapt new ways of working and initiatives supporting the strategy.* Influence - Using effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.* Networking & Partnerships - Building partnerships; developing and leveraging relationships within and across internal and external teams* Effective problem-solving and analytical skills, successfully navigating matrixed organizations, building consensus and influencing decision-making.* Strong communication skills to effectively engage with senior management and across all levels of the business.* Collaborative nature, with the ability to work with diverse personalities and collaborate effectively with various functions and stakeholders.* Strategic Planning - Prioritizing and planning; establishing an action plan for self and others to complete work efficiently and on time by setting priorities, establishing timelines and leveraging resources.**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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