Associate Director, Drug Product, Pulmovant

United StatesRemoteFull-timeexecutive

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Quick Summary

Overview

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for an Associate Director, Drug Product based in the United States.

Technical Tools

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We are seeking an experienced pharmaceutical development leader to oversee the development and advancement of an innovative inhaled dry powder drug product portfolio. In this role, you will drive formulation and process development, scale-up, technology transfer, and manufacturing readiness as programs progress toward regulatory registration and commercialization. You will collaborate closely with cross-functional teams and external manufacturing partners to ensure product quality, performance, and reliable clinical and future commercial supply. Applying Quality by Design principles and data-driven decision-making, you will identify technical risks, strengthen process controls, and support regulatory compliance throughout development. You will also contribute to critical CMC submissions, process validation, and commercial launch preparation. This opportunity is ideal for a technically accomplished professional who thrives in a lean biotechnology environment and wants to make a meaningful contribution to treatments addressing significant unmet medical needs.

Lead drug product formulation and process development for inhaled dry powder products, including scale-up, process characterization, technology transfer, and validation through external contract development and manufacturing organizations (CDMOs).
Apply Quality by Design (QbD) principles to identify Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs), establish appropriate control strategies, and support consistent product quality.
Compile, analyze, and trend drug product performance data and stability results using statistical tools such as JMP, translating findings into actionable recommendations for process improvements and specifications.
Oversee technical deliverables from external manufacturing partners and review key documentation, including master batch records, protocols, and technical reports, for accuracy, completeness, and compliance with Good Manufacturing Practice (GMP) requirements.
Support commercial manufacturing readiness, including planning and executing Process Performance Qualification (PPQ) activities and preparing for pre-approval inspections (PAIs).
Provide scientific and technical oversight of drug product and inhaler compatibility, container closure systems, and aerosol performance.
Represent Chemistry, Manufacturing, and Controls (CMC) on cross-functional project teams, coordinating milestones, resolving technical challenges, and tracking action items to maintain timelines and uninterrupted clinical trial material supply.
Lead drug product contributions to regulatory CMC submissions, including authoring Module 3 documentation and preparing responses to regulatory agency inquiries.
Collaborate with Drug Substance, Analytical Development, Clinical Supply, Quality, Regulatory Affairs, and external manufacturing partners to align technical activities and advance development objectives.
Provide technical leadership, guidance, and scientific recommendations to internal colleagues and external partners, taking ownership of complex decisions and development risks.

Requirements

~2 min read

Bachelor's, master's, or doctoral degree in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, Chemistry, or a related scientific or engineering discipline.
At least 10 years of drug product development experience, including substantial expertise in inhalation products and late-stage pharmaceutical development.
Demonstrated experience managing external CDMO relationships and owning technical deliverables for drug products progressing toward regulatory registration.
Hands-on expertise in inhalation formulation development, manufacturing process scale-up, drug-device compatibility, and aerodynamic performance testing.
Working knowledge of current Good Manufacturing Practice (cGMP), International Council for Harmonisation (ICH) guidelines, process validation, stability requirements, and regulatory expectations for combination products.
Experience with CMC Module 3 documentation and preparation of New Drug Applications (NDAs) or Marketing Authorisation Applications (MAAs) for inhaled products is preferred.
Strong analytical and problem-solving capabilities, including the ability to interpret statistical data, evaluate product and process performance, identify technical risks, and recommend evidence-based solutions.
Proven ability to coordinate complex technical activities across internal functions and external manufacturing partners while maintaining quality standards and project timelines.
Excellent communication, collaboration, and technical documentation skills, with the ability to explain complex scientific topics and provide clear recommendations.
Comfortable taking direct accountability, exercising sound technical judgment, and working independently in a lean, fast-paced biotechnology development environment.
Legally authorized to work in the United States, with the ability to meet applicable employment eligibility requirements.