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Job Summary: 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 MannKind'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.
Key Responsibilities:
• Lead Process Development Activities: Provide strategic and technical leadership for process development, scale-up, process characterization, technology transfer, and manufacturing-readiness activities across pipeline and lifecycle programs.
• Lead CMC Teams: Serve as CMC Lead for one or more development programs, chair cross-functional CMC teams, drive integrated plans, and align Process Development, Formulation, Analytical, Quality, Regulatory, Clinical Manufacturing, Supply Chain, and external partners.
• Late-Phase Development Strategy: Develop and execute phase-appropriate CMC strategies for Phase 2, Phase 3, registration, process validation, PPQ, and commercial launch readiness.
• Regulatory Leadership: Own or contribute to relevant Module 3 / IND / NDA / MAA CMC sections, support health authority interactions, and ensure CMC strategies are aligned with FDA, EMA, and other regulatory expectations.
• Technology Transfer and Manufacturing Readiness: Lead technology transfer activities, establish manufacturing control strategies, and ensure scalable, robust, and compliant processes.
• Quality and GMP Partnership: Partner effectively with Quality to ensure phase-appropriate GMP discipline, data integrity, investigation support, SOP alignment, and inspection readiness without creating unnecessary development burden. Proactively identify, assess, and mitigate quality and compliance risks while maintaining development agility and efficient program execution.
• Resource and Portfolio Management: Establish departmental priorities, manage resources and budgets, and ensure Process Development capabilities are aligned with CMC program needs and corporate priorities. Partner with senior leadership to evaluate portfolio opportunities, assess CMC investment requirements, and provide strategic recommendations that support corporate objectives and program success.
• Team Leadership: Build, lead, coach, and develop a high-performing Process Development team with clear accountability, strong cross-functional collaboration, and consistent execution against commitments.
• Risk Management and Escalation: Identify and manage technical, operational and program-level CMC risks, drive mitigation plans, make clear recommendations, and escalate issues early with options, tradeoffs, and decision points.
Qualifications:
• 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.
Preferred Skills:
• 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.
Pay Range: $224,000 - $336,000 per year