Associate Director, Drug Product, Pulmovant

This is a fully remote position, open to applicants in United States.

📋 Description

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

• Implement Quality by Design (QbD) principles to identify Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) while devising a comprehensive control strategy.

• Gather, analyze, and trend drug product performance data and stability findings utilizing statistical tools such as JMP; summarize results and propose process or specification modifications.

• Oversee CDMO technical deliverables and assess master batch records, protocols, and technical reports for accuracy, completeness, and compliance with GMP standards.

• Assist in commercial launch efforts, encompassing process performance qualification (PPQ) planning and execution as well as pre-approval inspection (PAI) preparedness.

• Provide scientific oversight regarding drug product and inhaler compatibility, container closure systems, and aerosol performance.

• Represent CMC within cross-functional project teams, ensuring timelines and action items are upheld to guarantee a continuous supply of clinical trial materials.

• Lead contributions to CMC submissions for drug products, including authoring Module 3 content and addressing inquiries from regulatory agencies.

• Offer technical guidance to cross-functional team members and external collaborators.

⛳️ Requirements

• BS, MS, or PhD in pharmaceutical sciences, pharmaceutics, chemical engineering, chemistry, or a related discipline.

• Over 10 years of experience in drug product development, with significant involvement in inhalation products and late-stage development.

• Proven experience managing external CDMO activities and technical deliverables for drug products progressing toward registration.

• Practical knowledge of inhalation formulation and process scale-up, compatibility of drugs and devices, and testing for aerodynamic performance.

• Familiarity with cGMP, ICH guidelines, process validation, stability requirements, and regulatory expectations for combination products.

• Preferred experience with Module 3 CMC documentation and NDA or MAA preparation for inhaled products.

• Ability to analyze data, evaluate technical risks, and facilitate decision-making across internal teams and external partners.

• Willingness to take direct responsibility within a lean development organization.

🏝️ Benefits

• Equal employment opportunities and protection from discrimination and harassment.

• Collaboration and innovation through the Roivant family of companies.