Associate Director, External Development and Manufacturing, Drug Product

MSD

. Lead formulation, device, process development, and current Good Manufacturing Practice drug product manufacturing activities at external providers .

Posted 10/27/2026full-timeUnited StatesSenior💰 $129,000 - $203,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in drug product manufacturing, compliance, and project management within the pharmaceutical industry, with a strong focus on vendor management and cross-functional collaboration. Proficient in Good Manufacturing Practices (GMP) and regulatory compliance, with a proven ability to optimize processes and drive operational excellence.

Highest-signal resume keywords

Drug Product ManufacturingGood Manufacturing Practices (GMP)Vendor ManagementClinical ManufacturingProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementData AnalysisRegulatory ComplianceRisk ManagementRoot Cause Analysis (RCA)Business Process DesignBusiness Process ImplementationBusiness Process ImprovementsPharmaceutical ManufacturingSolid Dosage Forms

Soft Skills

Excellent CommunicationFacilitation SkillsStakeholder EngagementStrategic ThinkingProblem Solving

Tools & Technologies

SAP

Industry Keywords

Pharmaceutical SciencesClinical Supplies ManagementExternal ManufacturingProcess DevelopmentDevice Development

About the role

Key responsibilities & impact

Lead formulation, device, process development, and current Good Manufacturing Practice drug product manufacturing activities at external providers
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 vendor relationships 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 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
Travel 10%

Requirements

What you’ll need

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
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 ability to navigate ambiguity and solve complex problems with rigor
Direct drug product manufacturing, specialized scientific, or device development experience preferred
Experience leading business process optimization, continuous improvement, or transformation initiatives preferred
Familiarity with SAP for material build and transactions preferred
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
Must be a US or Puerto Rico resident
Visa sponsorship is not available

Benefits

Comp & perks

Annual bonus and long-term incentive, if applicable
Medical, dental, and vision healthcare
Other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Hybrid work arrangement