Executive Director, Process Development & CMC Lead

Position:Executive Director, Process Development & CMC Lead

Location: Danbury, CT

Job :112980

# of Openings:1

Mann Kind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease. With deep expertise in drug-device combinations, Mann Kind aims to deliver therapies designed to fit seamlessly into daily life.
At Mann Kind, our employees are our greatest asset. We foster a close-knit, collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds, perspectives, and working styles as we work together to improve health outcomes and change lives.

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.

This position is located in Danbury, Ct and requires onsite presence Monday-Thursday, Fridays are remote.

• 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 elevate issues early with options, tradeoffs, and decision points.

• PhD in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biomedical Engineering, Mechanical Engineering, or a related field with 18+ years of relevant…