Director, External Development & Manufacturing

Job Description

Our companys 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 companys 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:

Preferred Skills:

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The salary range for this role is

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 employees 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 can apply for this role through (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

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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.

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