External Manufacturing Operations Director

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

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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.

Learn more about your rights, including under California, Colorado and other US State Acts

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.

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 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

*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.