Merck
External Manufacturing Operations Director
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The External Manufacturing Operations Director provides leadership in the areas of: Building relationships with our external partners Dispute resolution (with appropriate escalation) Strategic Production Planning Materials Management (Systems Applications and Products (SAP), End to End Planning, Logistics) Quality issues (Deviation Management, Product Release, Change Control) Technology issues (Technology transfers, Investigations, Process Improvements, etc.) Oversight of shop floor production and determining when an External Manufacturing Quality or Technology representative should be deployed to the External Party's facility Production System (MPS) and Continuous Improvement activities The responsibilities of the Operations Director include, but are not limited to: Partnering with the External Manufacturing leaders in the functional areas (e.g., Procurement, Quality, Technology, Finance, Legal, HR, etc.) to address broader business issues, customer needs, and opportunities Leading a cross-functional team with focus factory responsibility to ensure our products are manufactured, tested, and dispositioned safely and compliant to cGMPs Participating in the annual profit planning process, provides a monthly estimated actual on the organization's projected and actual spending and maintains a multi-year capital plan/budget Creating and maintaining a high-performance team organization and culture Ensuring External Party capacity information (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required, etc.) is provided for robust end-to-end planning activities Facilitating External Manufacturing Operations collaboration to leverage best practices & lessons learned across External Manufacturing Ops Participating in periodic Joint Steering Committee and Relationship Review Meetings (as appropriate) Contributing as a member of the applicable Value Chain Management Teams, as appropriate, charged with reducing overall cycle time, inventory, and supporting life cycle management activities Participating on the applicable Biologics Business Leadership Teams representing External Manufacturing Org and his/her respective external party relationships The Ops Director stays abreast with industry and policy changes and identifies implications and opportunities for their area of External Manufacturing and/or External Manufacturing Organization at large. Education Minimum Requirement: Bachelor's degree (a degree in Engineering, Science, or Business is preferred) MBA preferred Required Experience and Skills: A minimum ten (10) years' experience in commercial/business and/or manufacturing (in the following areas: operations, quality, technology, planning, procurement) function required (or equivalent of education/experience for PhDs) At least two (2) years of experience in management/leadership positions At least two (2) years of experience working in operations, technology, or quality manufacturing Antibody-drug conjugate (ADC) compounds Must possess excellent interpersonal, communication, collaboration, negotiation, and project management skills Has demonstrated strong leadership, managerial, problem-solving, and team building abilities and sensitivity to diverse cultures in current or past positions, which may include Employee Business Resource Group (EBRG) leadership experience such as Women's Network, LEAD, or mentoring Must possess the ability to work independently Must be decisive in an ambiguous environment Able to be the one face of our Company to the external party Has experience and ability to achieve compliance goals, through a risk-based approach with a deep understanding of cGMPs and EHS compliance, and compliance risk in Sterile Operations Has proven Lean Six Sigma skills to deliver compliant supply and achieve highest quality, lowest cost, and shortest lead-time Ability to apply understanding of end-to-end supply chain within external and internal networks and stakeholders across the network to achieve results and contribute to supply chain optimization Direct Health Authority Audit experience is desirable The role can be based at selective company sites across the United States and Europe. No relocation required. The salary range for this role is $169,700.00 - $267,200.00. 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 . You can apply for this role through
https://jobs.merck.com/us/en
(or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. 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. Search Firm Representatives Please Read Carefully: Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Required Skills: Business, Management Process, Manufacturing Preferred Skills: Job Posting End Date: 08/22/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The External Manufacturing Operations Director provides leadership in the areas of: Building relationships with our external partners Dispute resolution (with appropriate escalation) Strategic Production Planning Materials Management (Systems Applications and Products (SAP), End to End Planning, Logistics) Quality issues (Deviation Management, Product Release, Change Control) Technology issues (Technology transfers, Investigations, Process Improvements, etc.) Oversight of shop floor production and determining when an External Manufacturing Quality or Technology representative should be deployed to the External Party's facility Production System (MPS) and Continuous Improvement activities The responsibilities of the Operations Director include, but are not limited to: Partnering with the External Manufacturing leaders in the functional areas (e.g., Procurement, Quality, Technology, Finance, Legal, HR, etc.) to address broader business issues, customer needs, and opportunities Leading a cross-functional team with focus factory responsibility to ensure our products are manufactured, tested, and dispositioned safely and compliant to cGMPs Participating in the annual profit planning process, provides a monthly estimated actual on the organization's projected and actual spending and maintains a multi-year capital plan/budget Creating and maintaining a high-performance team organization and culture Ensuring External Party capacity information (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required, etc.) is provided for robust end-to-end planning activities Facilitating External Manufacturing Operations collaboration to leverage best practices & lessons learned across External Manufacturing Ops Participating in periodic Joint Steering Committee and Relationship Review Meetings (as appropriate) Contributing as a member of the applicable Value Chain Management Teams, as appropriate, charged with reducing overall cycle time, inventory, and supporting life cycle management activities Participating on the applicable Biologics Business Leadership Teams representing External Manufacturing Org and his/her respective external party relationships The Ops Director stays abreast with industry and policy changes and identifies implications and opportunities for their area of External Manufacturing and/or External Manufacturing Organization at large. Education Minimum Requirement: Bachelor's degree (a degree in Engineering, Science, or Business is preferred) MBA preferred Required Experience and Skills: A minimum ten (10) years' experience in commercial/business and/or manufacturing (in the following areas: operations, quality, technology, planning, procurement) function required (or equivalent of education/experience for PhDs) At least two (2) years of experience in management/leadership positions At least two (2) years of experience working in operations, technology, or quality manufacturing Antibody-drug conjugate (ADC) compounds Must possess excellent interpersonal, communication, collaboration, negotiation, and project management skills Has demonstrated strong leadership, managerial, problem-solving, and team building abilities and sensitivity to diverse cultures in current or past positions, which may include Employee Business Resource Group (EBRG) leadership experience such as Women's Network, LEAD, or mentoring Must possess the ability to work independently Must be decisive in an ambiguous environment Able to be the one face of our Company to the external party Has experience and ability to achieve compliance goals, through a risk-based approach with a deep understanding of cGMPs and EHS compliance, and compliance risk in Sterile Operations Has proven Lean Six Sigma skills to deliver compliant supply and achieve highest quality, lowest cost, and shortest lead-time Ability to apply understanding of end-to-end supply chain within external and internal networks and stakeholders across the network to achieve results and contribute to supply chain optimization Direct Health Authority Audit experience is desirable The role can be based at selective company sites across the United States and Europe. No relocation required. The salary range for this role is $169,700.00 - $267,200.00. 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 . You can apply for this role through
https://jobs.merck.com/us/en
(or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. 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. Search Firm Representatives Please Read Carefully: Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Required Skills: Business, Management Process, Manufacturing Preferred Skills: Job Posting End Date: 08/22/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.