Job Description

Senior Specialist, External Development & Manufacturing (ExDM) - Program Lead (P3)

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 the company's Research Laboratories drug product and device development sourcing strategy across all phases of small and large molecule research and development operations.

The Senior Specialist, External Development & Manufacturing (ExDM) Program Lead (P3) independently leads external manufacturing activities supporting clinical development. This role serves as the primary ExDM representative on cross-functional teams, integrating technical, operational, and financial workstreams to ensure reliable, compliant, clinical supply delivery. This role requires strong ownership, accountability, and collaboration, with a focus on executional excellence, continuous improvement, and strong external partnerships.

Key Responsibilities

• Lead execution of external manufacturing programs across Contract Manufacturing Organizations (CMOs), including planning, coordination, risk management, and issue resolution.

• Track and manage CMO key performance indicators (KPIs) and metrics to drive performance.

• Represent ExDM on project teams and align external manufacturing strategies with program objectives.

• Manage GMP-related activities such as batch record and specification review, change control, release support, investigations, and material coordination.

• Serve as the primary liaison with external partners, driving performance in quality, delivery, and cost.

• Oversee billing, purchase orders, and financial forecasting for assigned programs, while improving financial workflows and reporting.

• Collaborate across Technical Operations, Quality, Global Clinical Supplies, Procurement, and other partner groups to resolve complex technical and operational challenges.

• Identify and implement process improvements across internal workflows and vendor interfaces.

• Serve as a subject matter expert in selected technical or business areas and contribute to organizational capability building.

• Mentor and support junior team members through coaching, knowledge sharing, and project guidance.

• Use digital tools, analytics, and AI-enabled platforms to improve efficiency, decision-making, and communication.

Education Minimum Requirement:

• B.S. with minimum of 5 years relevant industrial experience, or

• M.S. with 3 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

• Working knowledge of GMP operations, batch release, investigations, and quality systems

• Strong project management, problem-solving, and stakeholder management skills

• Ability to work independently and lead effectively in a matrixed environment

Preferred Experience and Skills:

• Experience working with external partners or CMOs

• Advanced degree in a relevant discipline

• Experience leading external manufacturing or development programs

• Demonstrated success driving process improvements and scalable solutions

• Ability to influence across cross-functional teams and external partners

• Experience mentoring junior colleagues

• Digital fluency, including analytics and AI-enabled productivity tools

Required Skills:

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:

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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.

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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 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R400797