Associate Director, Drug Product, Pulmovant

Pulmovant

. Serve as a drug product technical leader for formulation and process development, scale-up, process characterization, technology transfer, and validation through external CDMOs .

Posted 10/14/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in drug product formulation and process development, with a strong focus on inhalation products and regulatory compliance. Proficient in applying Quality by Design principles and managing technical deliverables in collaboration with external CDMOs.

Highest-signal resume keywords

Drug Product DevelopmentInhalation FormulationQuality By Design (QbD)CGMP ComplianceModule 3 CMC Documentation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process DevelopmentStatistical AnalysisProcess CharacterizationTechnology TransferAerodynamic Performance TestingData AnalysisProcess ValidationCritical Quality Attributes (CQAs)Critical Process Parameters (CPPs)Regulatory Expectations

Soft Skills

LeadershipCollaborationAccountabilityCommunicationProblem-Solving

Tools & Technologies

JMPCDMO ManagementGMP StandardsStability Testing ToolsTechnical Report Review

Industry Keywords

Pharmaceutical SciencesChemical EngineeringInhaled ProductsNDA PreparationMAA PreparationICH GuidelinesCombination ProductsClinical Trial Material

About the role

Key responsibilities & impact

Serve as a drug product technical leader for formulation and process development, scale-up, process characterization, technology transfer, and validation through external CDMOs
Apply Quality by Design (QbD) principles to define Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) and develop a robust control strategy
Compile, analyze, and trend drug product performance data and stability results using statistical tools such as JMP; summarize findings and recommend process or specification actions
Manage CDMO technical deliverables and review master batch records, protocols, and technical reports for accuracy, completeness, and GMP compliance
Support commercial launch activities, including process performance qualification (PPQ) planning and execution and pre-approval inspection (PAI) readiness
Provide scientific oversight of drug product and inhaler compatibility, container closure systems, and aerosol performance
Represent CMC on cross-functional project teams, maintaining timelines and action items to ensure uninterrupted supply of clinical trial material
Lead drug product contributions to CMC submissions, including authoring Module 3 content and responding to agency inquiries
Provide technical guidance to cross-functional team members and external partners

Requirements

What you’ll need

BS, MS, or PhD in pharmaceutical sciences, pharmaceutics, chemical engineering, chemistry, or a related field
10+ years of drug product development experience, including substantial work with inhalation products and late-stage development
Demonstrated ownership of external CDMO activities and technical deliverables for a drug product advancing toward registration
Hands-on knowledge of inhalation formulation and process scale-up, drug and device compatibility, and aerodynamic performance testing
Working knowledge of cGMP, ICH guidelines, process validation, stability requirements, and regulatory expectations for combination products
Experience with Module 3 CMC documentation and NDA or MAA preparation for an inhaled product preferred
Ability to analyze data, assess technical risks, and drive decisions across internal functions and external partners
Comfort taking direct accountability in a lean development organization

Benefits

Comp & perks

Equal employment opportunities and protection from discrimination and harassment
Collaboration and innovation through the Roivant family of companies