External Manufacturing Operations Director
Merck, Durham, NC, United States
External Manufacturing Operations Director
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. We are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Join our team and contribute to our mission of using leading‑edge science to save and improve lives around the world.
The External Manufacturing Operations Director provides strategic and operational leadership for products manufactured by external partners supporting the Simtra site in Bloomington, IN. This role is accountable for ensuring reliable, high quality, and compliant supply by overseeing production planning, materials management, quality and technology issues, and day‑to‑day manufacturing performance. Acting as the primary operational interface with external manufacturing partners, the Ops Director leads issue resolution and escalation, ensures appropriate oversight of shop‑floor activities, and drives continuous improvement initiatives to enhance efficiency, quality, and supply reliability across the network.
Responsibilities
Provide leadership in dispute resolution with appropriate escalation
Oversee production planning and materials management (SAP entries, E2E Planning, Logistics)
Manage quality issues including deviation management, product release, and change control
Address technology issues such as technology transfers, investigations, and process improvements
Supervise shop floor production and determine when an ExM Quality or Technology representative should be deployed to the External Party’s facility
Lead MPS and continuous improvement activities
Partner with ExM leaders in functional areas (e.g., Procurement, Quality, Technology, Finance, Legal, HR) to address broader business issues, customer needs, and opportunities
Participate in the annual profit planning process and provide monthly estimated actuals on projected and actual spending
Maintain a multi‑year capital plan/budget
Handle people‑related matters including staffing, employee development, performance & compensation management, employee relations, and retention
Create and maintain a high‑performance team organization and culture
Ensure External Party capacity information is provided for robust end‑to‑end planning activities
Create and maintain an External Manufacturing Organization Handbook containing Global ExM policies, procedures, templates, etc.
Facilitate EM Operations Manager collaboration to leverage best practices and lessons learned across ExM Ops
Participate in periodic Business and Relationship Review Meetings
Serve as a member of applicable Value Chain Management Teams to reduce overall cycle time, inventory, and support life cycle management activities
Represent ExM Org on applicable Tactical Ring and/or Business Leadership Teams (Pharm, Chemical, and Sterile)
Stay abreast of industry and policy changes and identify implications and opportunities for ExM and/or ExM Organization at large
Qualifications Required
Bachelor’s degree in Engineering, Science, or Business; Master’s degree preferred.
A minimum of ten (10) years’ experience in commercial, business, and/or manufacturing (within experience in operations, quality, technology, planning, procurement) function
Excellent interpersonal, communication, collaboration, negotiation, and project management skills
Demonstrated strong leadership, managerial, problem‑solving, and team‑building abilities
Sensitivity to diverse cultures
Ability to work independently with minimal coaching
Decisive in ambiguous environments
Able to represent our company to the external party
Required Skills API Manufacturing, Biotechnology Manufacturing, CMO Management, Contract Management, Cross‑Cultural Awareness, Cross‑Functional Project Management, Dispute Resolution, Driving Continuous Improvement, External Manufacturing, Financial Acumen, Global Experience, Manufacturing Technologies, Medical Device Manufacturing, People Leadership, Proactive Thinking, Production Planning, Production Scheduling, Quality Systems Design, Risk Mitigation Strategies, Sterile Manufacturing
Compensation & Benefits The salary range for this role is $173,200.00 – $272,600.00.
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.
Work Arrangements Hybrid work model: employees in office‑based positions will work a hybrid schedule consisting of three days on‑site per week, Monday‑Thursday, with Friday as a remote‑working day, unless business critical tasks require an on‑site presence.
Travel requirements: 25%.
Legal 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. Know Your Rights, and EEOC GINA Supplement. We are proud to be a company that embraces the value of bringing together talented, and committed people with diverse experiences, perspectives, skills and backgrounds.
#J-18808-Ljbffr
The External Manufacturing Operations Director provides strategic and operational leadership for products manufactured by external partners supporting the Simtra site in Bloomington, IN. This role is accountable for ensuring reliable, high quality, and compliant supply by overseeing production planning, materials management, quality and technology issues, and day‑to‑day manufacturing performance. Acting as the primary operational interface with external manufacturing partners, the Ops Director leads issue resolution and escalation, ensures appropriate oversight of shop‑floor activities, and drives continuous improvement initiatives to enhance efficiency, quality, and supply reliability across the network.
Responsibilities
Provide leadership in dispute resolution with appropriate escalation
Oversee production planning and materials management (SAP entries, E2E Planning, Logistics)
Manage quality issues including deviation management, product release, and change control
Address technology issues such as technology transfers, investigations, and process improvements
Supervise shop floor production and determine when an ExM Quality or Technology representative should be deployed to the External Party’s facility
Lead MPS and continuous improvement activities
Partner with ExM leaders in functional areas (e.g., Procurement, Quality, Technology, Finance, Legal, HR) to address broader business issues, customer needs, and opportunities
Participate in the annual profit planning process and provide monthly estimated actuals on projected and actual spending
Maintain a multi‑year capital plan/budget
Handle people‑related matters including staffing, employee development, performance & compensation management, employee relations, and retention
Create and maintain a high‑performance team organization and culture
Ensure External Party capacity information is provided for robust end‑to‑end planning activities
Create and maintain an External Manufacturing Organization Handbook containing Global ExM policies, procedures, templates, etc.
Facilitate EM Operations Manager collaboration to leverage best practices and lessons learned across ExM Ops
Participate in periodic Business and Relationship Review Meetings
Serve as a member of applicable Value Chain Management Teams to reduce overall cycle time, inventory, and support life cycle management activities
Represent ExM Org on applicable Tactical Ring and/or Business Leadership Teams (Pharm, Chemical, and Sterile)
Stay abreast of industry and policy changes and identify implications and opportunities for ExM and/or ExM Organization at large
Qualifications Required
Bachelor’s degree in Engineering, Science, or Business; Master’s degree preferred.
A minimum of ten (10) years’ experience in commercial, business, and/or manufacturing (within experience in operations, quality, technology, planning, procurement) function
Excellent interpersonal, communication, collaboration, negotiation, and project management skills
Demonstrated strong leadership, managerial, problem‑solving, and team‑building abilities
Sensitivity to diverse cultures
Ability to work independently with minimal coaching
Decisive in ambiguous environments
Able to represent our company to the external party
Required Skills API Manufacturing, Biotechnology Manufacturing, CMO Management, Contract Management, Cross‑Cultural Awareness, Cross‑Functional Project Management, Dispute Resolution, Driving Continuous Improvement, External Manufacturing, Financial Acumen, Global Experience, Manufacturing Technologies, Medical Device Manufacturing, People Leadership, Proactive Thinking, Production Planning, Production Scheduling, Quality Systems Design, Risk Mitigation Strategies, Sterile Manufacturing
Compensation & Benefits The salary range for this role is $173,200.00 – $272,600.00.
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.
Work Arrangements Hybrid work model: employees in office‑based positions will work a hybrid schedule consisting of three days on‑site per week, Monday‑Thursday, with Friday as a remote‑working day, unless business critical tasks require an on‑site presence.
Travel requirements: 25%.
Legal 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. Know Your Rights, and EEOC GINA Supplement. We are proud to be a company that embraces the value of bringing together talented, and committed people with diverse experiences, perspectives, skills and backgrounds.
#J-18808-Ljbffr