Executive Director, Process Development & CMC Strategy

BioCT Innovation Commons; Danbury (CT); Hybrid; USD 180,000 - 240,000; Full time

Job summary

MannKind Corporation seeks a Process Development & CMC Lead to steer process development, scale-up, tech transfer, and regulatory CMC activities across development programs in a fast-paced setting. The role includes ownership of Phase 2/3 strategies, PPQ planning, and readiness for commercial launch of inhaled or advanced drug products.

The ideal candidate has extensive late-phase experience, cross-functional leadership, and strong communication with senior leadership to guide regulatory

Qualifications

• PhD in chemical engineering or related field with 18+ years of pharmaceutical development, or MS/BS with 20+ years of relevant experience.
• Extensive people-management experience leading scientists, engineers, managers, or cross-functional teams.
• Proven experience leading Process Development, Manufacturing Science and Technology, Technical Operations, or CMC functions for complex products.
• Proven experience as CMC Lead, program technical lead, or equivalent cross-functional development leader.
• Direct late-phase development experience, including Phase 3 execution, regulatory submissions, process validation, PPQ planning, and launch readiness.
• Strong understanding of drug product, drug substance, analytical, formulation, process development, manufacturing, and regulatory CMC interdependencies.
• Experience with technology transfer to internal sites and/or CDMOs.
• Experience authoring, reviewing, or defending CMC sections of regulatory filings and dealing with health authority questions or inspections.
• Strong communication, collaboration, and stakeholder-management skills for senior leadership.
• Ability to operate in a fast-paced, resource-constrained development environment with shifting priorities.

Responsibilities

• Lead Process Development Activities: strategic and technical leadership for process development, scale-up, characterization, technology transfer, and manufacturing-readiness.
• Lead CMC Teams: chair cross-functional teams, drive integrated plans, and align processes across multiple functions.
• Develop phase-appropriate CMC strategies for Phase 2/3, registration, validation, PPQ, and commercial launch readiness.
• Regulatory Leadership: contribute to Module 3/IND/NDA/MAA CMC sections and interact with health authorities.
• Technology Transfer and Manufacturing Readiness: manage technology transfer and establish robust control strategies.
• Quality & GMP Partnership: ensure GMP adherence, data integrity, and inspection readiness.
• Resource and Portfolio Management: align capabilities with program needs and corporate priorities.
• Team Leadership: build and coach a high-performing Process Development team.
• Risk Management: identify and mitigate technical and program risks with clear options and escalation.

Skills

People management

Leadership

CMC leadership

Late-phase development

Regulatory knowledge

Communication

Cross-functional collaboration

Quality & GMP

Risk management

Technical translation to leadership

Education

PhD in Chemical Engineering or related field (18+ years)

Job description

MannKind Corporation seeks a Process Development & CMC Lead to steer process development, scale-up, tech transfer, and regulatory CMC activities across development programs in a fast-paced setting. The role includes ownership of Phase 2/3 strategies, PPQ planning, and readiness for commercial launch of inhaled or advanced drug products.

The ideal candidate has extensive late-phase experience, cross-functional leadership, and strong communication with senior leadership to guide regulatory