Director, External Manufacturing Operations
Merck, West Point, PA, United States
Our Company's Global Pharmaceutical Operations (GPO) External Manufacturing organization is responsible for management of contract manufacturing organizations (CMO) of our Company’s products across drug substance, drug product and packaging operations. The organization helps launch and supply our critical medicines and vaccines around the world.
Within our GPO External Manufacturing organization, the Integrated Launch Excellence Platform is responsible for converting our pipeline to products through commercialization activities at CMOs for Drug Substance and Drug Products. Additionally, the Platform has responsibility for accelerating our regionalization strategies and ensuring CMOs manufacturing our acquired assets are integrated into our external network. The scope of activity, along with the partner groups, encompasses strategic sourcing and technical transfer phased from pre‑PPQ through post‑launch builds for sustained, reliable compliant supply at a competitive cost.
The Director of Operations will interact with key operational and functional leaders and will be a leader for critical products and transfers focused on small molecule drug substance and/or drug products. The leader will be required to communicate, influence, and manage across the business as well as with partners in stakeholder organizations, such as Development & Commercialization Teams (DCT), Value Chain Management (VCM), Science & Technology (S&T), Procurement, Quality, and others to achieve outcomes.
The incumbent and their team represent the primary point of contact for all dealings between the Company and the assigned CMO with emphasis on establishing a strong partnership as well as boundaries and ground rules of engagement founded on the spirit of contractual terms. These business relationships are typically highly complex in nature and of strategic importance, both to sustain the business and to grow the business.
Primary Activities Include, But Are Not Limited To
The candidate leads an organization with direct oversight of the relationship with the CMO, serving as the air traffic controller of all information/interactions between the Company and the CMO, establishing boundaries and rules of engagement, focusing on building the strength of the internal/external partnership, issue escalation of any type, and developing recommendations.
Represents External Manufacturing operations on the cross‑functional teams with DCT, VCM, S&T, and Procurement to enable stand‑up and delivery of 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 opportunities; Steers issue escalation through 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); 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; 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.
Education Minimum Requirement
Bachelor’s degree minimum in Engineering or Science (preferred)
Minimum ten (10) years’ experience in small molecule drug substance and/or drug product manufacturing (operations, quality, or technology).
Required Experience
Compliance – Experience and ability to achieve GMP and EHS compliance goals, through a risk‑based approach across Drug Substance and/or Drug Product.
Operational Excellence – Proven Lean Six Sigma skills to deliver compliant supply and achieve highest quality, lowest cost, and shortest lead‑time.
Depth of Manufacturing Knowledge – Proven skills and expertise at management level drug substance and drug product platforms.
New Product Introduction & Technical Transfer – 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.
Preferred Experience
Business & Financial Acumen – Ability to understand and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.
Accomplishment oriented, self‑motivated, persistent, with a “business owner” mentality, the ability to influence without authority, and 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. Prioritize conflicting demands, act with urgency, and follow up effectively on tasks and activities.
Innovative thinking to experiment, learn and adapt new ways of working and initiatives supporting the strategy.
Enterprise Leadership Skills
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.
Required Skills Cross‑Cultural Awareness, Data‑Driven Decision Making, Drug Product Manufacturing, External Manufacturing, GMP Compliance, Innovation, Operational Excellence, Process Improvements, Procurement, Production Management, Production Planning, Small Molecules, Strategic Thinking
Location Requirement U.S. And Puerto Rico Residents Only.
EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement. We are proud to embrace the value of bringing together talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other U.S. State Acts.
Work Arrangement U.S. Hybrid Work Model: Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a Hybrid work consisting of three total days on‑site per week, Monday – Thursday, with Friday designated as a remote‑working day unless business critical tasks require an on‑site presence. This Hybrid work model does not apply to field‑based positions; facility‑based, manufacturing‑based, or research‑based positions located at a Company site; positions covered by a collective‑bargaining agreement; or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. This Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Compensation and Benefits Salary range: $173,200.00 – $272,600.00. The lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
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Within our GPO External Manufacturing organization, the Integrated Launch Excellence Platform is responsible for converting our pipeline to products through commercialization activities at CMOs for Drug Substance and Drug Products. Additionally, the Platform has responsibility for accelerating our regionalization strategies and ensuring CMOs manufacturing our acquired assets are integrated into our external network. The scope of activity, along with the partner groups, encompasses strategic sourcing and technical transfer phased from pre‑PPQ through post‑launch builds for sustained, reliable compliant supply at a competitive cost.
The Director of Operations will interact with key operational and functional leaders and will be a leader for critical products and transfers focused on small molecule drug substance and/or drug products. The leader will be required to communicate, influence, and manage across the business as well as with partners in stakeholder organizations, such as Development & Commercialization Teams (DCT), Value Chain Management (VCM), Science & Technology (S&T), Procurement, Quality, and others to achieve outcomes.
The incumbent and their team represent the primary point of contact for all dealings between the Company and the assigned CMO with emphasis on establishing a strong partnership as well as boundaries and ground rules of engagement founded on the spirit of contractual terms. These business relationships are typically highly complex in nature and of strategic importance, both to sustain the business and to grow the business.
Primary Activities Include, But Are Not Limited To
The candidate leads an organization with direct oversight of the relationship with the CMO, serving as the air traffic controller of all information/interactions between the Company and the CMO, establishing boundaries and rules of engagement, focusing on building the strength of the internal/external partnership, issue escalation of any type, and developing recommendations.
Represents External Manufacturing operations on the cross‑functional teams with DCT, VCM, S&T, and Procurement to enable stand‑up and delivery of 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 opportunities; Steers issue escalation through 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); 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; 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.
Education Minimum Requirement
Bachelor’s degree minimum in Engineering or Science (preferred)
Minimum ten (10) years’ experience in small molecule drug substance and/or drug product manufacturing (operations, quality, or technology).
Required Experience
Compliance – Experience and ability to achieve GMP and EHS compliance goals, through a risk‑based approach across Drug Substance and/or Drug Product.
Operational Excellence – Proven Lean Six Sigma skills to deliver compliant supply and achieve highest quality, lowest cost, and shortest lead‑time.
Depth of Manufacturing Knowledge – Proven skills and expertise at management level drug substance and drug product platforms.
New Product Introduction & Technical Transfer – 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.
Preferred Experience
Business & Financial Acumen – Ability to understand and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.
Accomplishment oriented, self‑motivated, persistent, with a “business owner” mentality, the ability to influence without authority, and 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. Prioritize conflicting demands, act with urgency, and follow up effectively on tasks and activities.
Innovative thinking to experiment, learn and adapt new ways of working and initiatives supporting the strategy.
Enterprise Leadership Skills
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.
Required Skills Cross‑Cultural Awareness, Data‑Driven Decision Making, Drug Product Manufacturing, External Manufacturing, GMP Compliance, Innovation, Operational Excellence, Process Improvements, Procurement, Production Management, Production Planning, Small Molecules, Strategic Thinking
Location Requirement U.S. And Puerto Rico Residents Only.
EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement. We are proud to embrace the value of bringing together talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other U.S. State Acts.
Work Arrangement U.S. Hybrid Work Model: Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a Hybrid work consisting of three total days on‑site per week, Monday – Thursday, with Friday designated as a remote‑working day unless business critical tasks require an on‑site presence. This Hybrid work model does not apply to field‑based positions; facility‑based, manufacturing‑based, or research‑based positions located at a Company site; positions covered by a collective‑bargaining agreement; or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. This Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Compensation and Benefits Salary range: $173,200.00 – $272,600.00. The lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
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