Associate Director, External Development and Manufacturing, Drug Product

Merck & Co.; Rahway (NJ); Hybrid; USD 129,000 - 203,000; Full time

Benefits offered by this job

Annual bonus and long-term incentive

Medical, dental, vision insurance

401(k) retirement benefits

Paid holidays and vacation

Job summary

Merck & Co. in Rahway, NJ is seeking an Associate Director to lead formulation, device, process development, and external drug product manufacturing activities at contract providers.

You will work in matrix teams across Product Development, Quality, Analytical, Procurement, and Global Clinical Supply to advance oral solid dosage forms, biologics, vaccines, and device combinations. The role emphasizes vendor management, project leadership, and regulatory compliance within GMP frameworks, with

Qualifications

• Relevant pharmaceutical development and external manufacturing experience.
• Vendor and project management with cross-functional delivery.
• GMP knowledge and regulatory compliance in drug product development.

Responsibilities

• Plan and coordinate formulation, device, process development, and clinical manufacturing at CROs/CMOs.
• Provide manufacturing and compliance expertise to project teams; manage timelines and risks.
• Develop proposals and evaluate vendors for fit, capacity, and geography.
• Maintain vendor relationships aligned with pipeline needs across products.
• Support technology evaluations and ensure appropriate scope and agreements.
• Collaborate to optimize externalization and portfolio-level excellence.
• Provide business/logistical support for non-manufacturing activities including device development.
• Travel approximately 10%.

Skills

GMP knowledge

Regulatory compliance

Vendor management

Cross-functional collaboration

Project management

Excellent communication

Strategic thinking

Root Cause Analysis (RCA)

Clinical manufacturing

Data analysis

Education

B.S. with 8 years experience

M.S. with 6 years

Ph.D. with 4 years

Tools

SAP

Job description

Job Description

Our company's Pharmaceutical Sciences and Device Development organization translates molecules into medicines from discovery through registration by designing, developing, scaling, and transferring formulations, devices, and manufacturing processes. The External Development and Manufacturing team executes the drug product and device sourcing strategy across small- and large-molecule research and development.

The Associate Director independently leads formulation, device, process development, and current Good Manufacturing Practice drug product manufacturing activities at external providers. Working within matrix teams that include product development, Quality, Analytical, Procurement, and Global Clinical Supply, the role supports oral solid dosage forms, biologics, vaccines, specialty products, and drug-device combinations. The position also contributes to operational excellence, external network strategy, and productive vendor relationships.

Key Responsibilities

• Plan and coordinate formulation, device, process development, and clinical manufacturing activities at contract research and manufacturing organizations.
• Provide manufacturing, compliance, and execution expertise to project teams; manage timelines, deliverables, risks, and issue resolution.
• Develop project requests for proposals; evaluate responses and recommend vendors based on technical fit, unit operations, safety classification, capacity, timing, geography, and clinical supply needs.
• Identify, establish, and maintain trusted vendor relationships aligned with pipeline needs across oral formulation, sterile and specialty products, device development, and discovery pharmaceutical sciences.
• Support technology evaluations through external partner discussions, confidentiality agreements, technical information exchange, and guidance on appropriate scope and agreement structure.
• Collaborate across scientific and operational functions to optimize externalization activities, improve workflows, and advance portfolio-level operational excellence.
• Provide business and logistical support for non-manufacturing activities, including device development, device evaluation, and process development.
• 10% Travel

Education Minimum Requirement

• B.S. with at least 8 years of relevant industrial experience, or
• M.S. with at least 6 years, or
• Ph.D. with at least 4 years in Chemical Engineering, Pharmaceutical Sciences, or a related engineering or scientific discipline.

Required Experience and Skills

• Relevant pharmaceutical development, clinical manufacturing, supply chain, or external manufacturing experience.
• Demonstrated vendor and project management, cross-functional collaboration, and independent execution of business deliverables.
• Strong knowledge of GMP, regulatory expectations, manufacturing compliance, and drug product development.
• Excellent communication, facilitation, and stakeholder engagement skills with the ability to influence teams without direct authority.
• Strategic thinking, business acumen, creativity, sound judgment, and the ability to navigate ambiguity and solve complex problems with rigor.

Preferred Experience and Skills

• Direct drug product manufacturing, specialized scientific, or device development experience.
• Experience leading business process optimization, continuous improvement, or transformation initiatives.
• Familiarity with SAP for material build and transactions

Required Skills

Business Process Design, Business Process Implementation, Business Process Improvements, Clinical Manufacturing, Clinical Supplies Management, Clinical Trial Management, Data Analysis, Good Manufacturing Practices (GMP), Pharmaceutical Manufacturing, Pharmaceutical Sciences, Regulatory Compliance, Risk Management, Root Cause Analysis (RCA), Solid Dosage Forms, Vendor Management

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.

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.

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is: $129,000.00 - $203,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 .

The primary location for this posting is: USA - New Jersey - Rahway

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information

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

11/21/2026

*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.

Requisition ID

R423819