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Executive Director, Process Development & CMC Lead
Job Location:
Job Location:
Danbury, CT - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
20 August 2026 (23 hours ago)
Posted:
Application Deadline:
17 November 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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 MannKinds 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.
Required Experience:
Director
About Company
Drawing on the legacy of innovator and humanitarian Alfred E. Mann, our team of passionate scientists, researchers, and professionals develops cutting-edge therapeutic products and technologies that help people take control of their health and live—fully humann.
