Director of Drug Product Development

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director of Drug Product Development in the United States.

This senior leadership role offers the opportunity to oversee the development, scale-up, and commercial readiness of inhaled drug products, particularly dry powder formulations. The Director will lead cross-functional teams spanning drug substance, clinical, quality, regulatory, and external CDMO partners to ensure high-quality, compliant, and timely delivery of late-stage clinical and commercial drug products. This position emphasizes strategic oversight, technical expertise, and operational excellence in process development, manufacturing, and regulatory compliance. The ideal candidate will combine scientific rigor with strong project management and mentoring skills, driving product success from Phase 2/3 through commercial launch. You will work in a dynamic, collaborative, and fast-paced environment that values innovation, precision, and measurable impact on patient outcomes.

Accountabilities:

·        Serve as the technical lead for inhalation drug product development, ensuring manufacturability, performance, and lifecycle management.

·        Lead Phase 3 process characterization, validation, and execution of registration batches at external CDMOs.

·        Provide scientific oversight on formulation development, device compatibility, and container–closure systems.

·        Collaborate with cross-functional teams to support method validation, product specifications, and stability studies for regulatory filings.

·        Partner with Quality, Regulatory, and Supply Chain teams to ensure cGMP compliance and readiness for pre-approval inspections.

·        Manage technology transfers, manufacturing documentation, and process validation protocols and reports.

·        Mentor and provide technical guidance to junior staff and matrixed contributors.

Requirements

·        15+ years of experience in inhalation drug product development, preferably dry powder inhalation.

·        Proven success advancing inhalation products through late-stage development (Phase 2b/3) and into registration.

·        Hands-on experience with formulation, process scale-up, drug-device compatibility, and aerodynamic performance testing (APSD, delivered dose).

·        Strong knowledge of cGMPs, ICH guidelines, and regulatory expectations for combination products.

·        Demonstrated ability to manage CDMOs, including oversight of deliverables, timelines, and budgets.

·        Familiarity with Module 3 CMC documentation, process validation, and stability data requirements.

·        Experience supporting NDA/MAA submissions for inhaled products preferred.

·        Advanced skills in data analysis, risk assessment (QbD, DoE, FMEA), and cross-functional collaboration.

·        Exceptional communication and leadership skills, with experience in fast-paced, high-accountability environments.

Benefits

·        Competitive salary commensurate with experience.

·        Comprehensive healthcare coverage including medical, dental, and vision.

·        Retirement savings plans with company contributions.

·        Paid vacation, sick leave, and wellness resources.

·        Professional development and mentorship opportunities.

·        Flexible work environment, including remote work options.

·        Inclusive and collaborative organizational culture.

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.
When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.
🔍 Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience, and achievements.
📊 It compares your profile to the job’s core requirements and past success factors to determine your match score.
🎯 Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role.
🧠 When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.
The process is transparent, skills-based, and free of bias — focusing solely on your fit for the role.
Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team.
Thank you for your interest!

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