External Manufacturing Operations Director
NCBiotech, Durham, NC, United States
Job Description
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
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, although the specific days may vary by site or organization, 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, and daily in‑person attendance is required for, field‑based positions; facility‑based, manufacturing‑based, or research‑based positions where the work to be performed is located at a Company site; positions covered by a collective‑bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The salary range for this role is $173,200.00 - $272,600.00. This is 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.
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 be a company that embraces 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.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
04/18/2026
Requisition ID:
R392353
#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
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, although the specific days may vary by site or organization, 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, and daily in‑person attendance is required for, field‑based positions; facility‑based, manufacturing‑based, or research‑based positions where the work to be performed is located at a Company site; positions covered by a collective‑bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The salary range for this role is $173,200.00 - $272,600.00. This is 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.
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 be a company that embraces 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.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
04/18/2026
Requisition ID:
R392353
#J-18808-Ljbffr