Director, External Development & Manufacturing

Job Description

Our company's Pharmaceutical Sciences and Device Development (PSDD) organization translates molecules to medicines, working from the discovery interface through registration stability manufacturing by designing, developing and scaling-up the formulation, device, and manufacturing process. Driving drug product design from the bench to Good Manufacturing Practice (GMP) manufacturing facilities, our scientists and engineers use cutting edge science to transform drug delivery and manufacturing technology to positively impact patients. The External Development and Manufacturing (ExDM) team within PSDD is focused on executing our company's Research Laboratories drug product and device development sourcing strategy across all phases of small and large molecule research and development operations.

The Director, External Development & Manufacturing (ExDM) professional serves as a senior individual contributor responsible for shaping and executing external development and manufacturing strategies across complex drug product programs. This role operates with broad influence across pharmaceutical sciences, driving alignment between internal stakeholders and external partners to deliver high-quality, compliant, and efficient outcomes. The successful candidate will be recognized as a subject matter expert, contributing to strategic direction, vendor network optimization, and enterprise-level process improvements while leading critical initiatives and special assignments.

 

Key Responsibilities

Strategic Leadership and Execution

• Translate organizational and portfolio priorities into executable strategies across ExDM programs and vendor networks

• Contribute to department and enterprise-level strategic objectives, including alignment of external capabilities with pipeline needs

• Identify opportunities for innovation, operational excellence, and transformation across development and manufacturing processes

• Lead and influence cross-functional initiatives and committees, representing ExDM perspectives in strategic decision-making forums

• Serve as a strategic advisor on complex programs, development strategies, and supply approaches

Vendor Strategy and External Partnerships

• Proactively shape and optimize select external vendor networks to meet evolving technical and portfolio requirements

• Develop and maintain strong, trust-based relationships with CDMOs to ensure alignment, performance, and long-term value

• Act as a primary liaison and subject matter expert for key vendors, driving continuous improvement in technical execution and collaboration models

• Evaluate and influence vendor selection, capability assessment, and partnership strategies in collaboration with procurement and partner functions

Process Excellence and Continuous Improvement

• Identify, champion, and implement business process improvements across ExDM and at the internal/external interface

• Lead complex, cross-functional improvement initiatives from concept through implementation, ensuring measurable outcomes

• Establish and apply best practices, governance approaches, and standardized ways of working to enhance efficiency and reliability

• Drive a culture of proactive risk management, issue resolution, and continuous learning

Program and Portfolio Leadership

• Independently represent ExDM on complex, high-impact programs, ensuring delivery of development and manufacturing objectives

• Manage and influence across multiple stakeholders without direct authority to achieve program goals

• Lead special assignments, including strategic projects, digital initiatives, or transformation efforts that span functions or programs

• Provide expert guidance on technical, operational, and compliance considerations across a broad range of modalities and dosage forms

Stakeholder Engagement and Communication

• Build and sustain strong networks across Development, Finance, Manufacturing, Quality, Procurement, and other key functions

• Facilitate alignment through effective communication, structured governance, and engagement with senior stakeholders

• Present complex ideas clearly, influence decisions, and drive adoption of new approaches or strategies

Education Minimum Requirement:

B.S. with minimum of 14 years relevant industrial experience, or M.S. with 10 years of experience in Chemical Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline.

Required Experience and Skills:

• Relevant experience in clinical manufacturing, supply chain, or external manufacturing management within the pharmaceutical industry

• Significant experience in pharmaceutical development, manufacturing, or external operations

• Demonstrated expertise in vendor management, program execution, and cross-functional collaboration

Skills and Competencies

• Strong strategic thinking and business acumen

• Proven ability to lead and influence in a matrix environment without direct authority

• Experience driving process improvements and transformation initiatives

• Deep understanding of GMP and regulatory considerations

• Excellent communication, facilitation, and stakeholder engagement skills

• Ability to navigate ambiguity and solve complex problems with creativity and rigor

Required Skills:

Adaptability, Adaptability, Budget Development, Chemical Engineering, Cross-Functional Collaboration, Cross-Functional Leadership, Decision Making, Design, Facilitation, Feasibility Studies, GMP Compliance, Performance Monitoring, Pharmaceutical Development, Pharmaceutical Sciences, Process Improvements, Program Execution, Project Management, Project Planning, Regulatory Compliance, Resource Allocation, Results-Oriented, Risk Management, Stakeholder Engagement, Strategic Planning, Strategic Thinking {+ 2 more}

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

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

07/15/2026

*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.