Executive Director, Process Development & CMC Lead

Process Development & CMC Lead

The Process Development & CMC Lead will provide strategic and technical leadership for the Process Development group while also serving as the CMC Lead for one or more development programs. This role is responsible for process development, scale-up, technology transfer, manufacturing readiness, and integrated CMC execution across Mann Kind's pipeline. The ideal candidate will have significant late-phase development experience, including Phase 3 execution, regulatory submissions, process validation, PPQ strategy, and commercial launch readiness for complex, inhaled, or particle-engineered products.

• Lead Process Development Activities
• Lead CMC Teams
• Late-Phase Development Strategy
• Regulatory Leadership
• Technology Transfer and Manufacturing Readiness
• Quality and GMP Partnership
• Resource and Portfolio Management
• Team Leadership
• Risk Management and Escalation

PhD in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biomedical Engineering, Mechanical Engineering, or a related field with 18+ years of relevant experience; or MS/BS with 20+ years of relevant pharmaceutical development experience.

Significant people-management experience leading scientists, engineers, managers, or cross-functional technical teams.

Demonstrated experience leading Process Development, Manufacturing Science and Technology, Technical Operations, or CMC functions for complex pharmaceutical products.

Proven experience serving as a CMC Lead, program technical lead, or equivalent cross-functional development leader.

Direct late-phase development experience, ideally including Phase 3 execution, NDA/MAA preparation, process validation, PPQ planning, and commercial launch readiness.

Strong understanding of drug product, drug substance, analytical, formulation, process development, manufacturing, and regulatory CMC interdependencies.

Experience with technology transfer to internal manufacturing sites and/or CDMOs.

Experience authoring, reviewing, or defending CMC sections of regulatory filings and supporting health authority questions or inspections.

Strong communication, collaboration, and stakeholder-management skills, including the ability to communicate complex technical issues clearly to senior leadership.

Ability to operate effectively in a fast-paced, resource-constrained development environment with shifting priorities.

Experience with inhaled drug products, dry powder inhalers, particle-engineered products, complex dosage forms, or drug-device combination products.

Experience taking at least one product through late-stage development, regulatory submission, validation, approval, or commercial launch.

Familiarity with QbD, control strategy development, process characterization, continued process verification, and lifecycle management.

Experience working with FDA, EMA, notified bodies, or other regulatory agencies on CMC, combination product, or manufacturing-readiness topics.

Experience building or improving development-stage CMC infrastructure, operating models, decision frameworks, SOPs, templates, or governance practices.

Experience leading teams through technical disagreement, quality interface issues, and cross-functional decision-making with a clear, collaborative, and accountable style.