Executive Director, Process Development & CMC Lead

Mann Kind Corporation is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient‑centric solutions, developing and commercializing innovative inhaled therapeutics and drug‑device technologies aimed at addressing serious unmet needs across endocrine, cardiorenal, and orphan lung diseases. The company applies deep expertise in formulation science and inhalation‑device engineering to reduce the treatment burden for conditions such as diabetes, congestive heart failure, pulmonary fibrosis, and pulmonary hypertension.

Mann Kind’s core technologies, including ultrafine dry‑powder formulations and advanced inhalation platforms, enable rapid, convenient delivery of medicines directly to the deep lung. This approach supports both local pulmonary targeting and systemic delivery for various medical indications. Through alternative drug formulations and delivery mechanisms, Mann Kind aims to bring forward differentiated, patient‑centric therapies that expand treatment options to improve outcomes across chronic and rare diseases.

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.

• 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…