Executive Director, Process Development & CMC Lead
MannKind Corporation
August 19, 2026
Remote friendly (Danbury, CT)
United States
$224,000 - $336,000 USD yearly
Operations
Job Summary:
The Process Development & CMC Lead provides strategic and technical leadership for the Process Development group and serves as the CMC Lead for one or more development programs. Responsibilities include process development, scale-up, technology transfer, manufacturing readiness, and integrated CMC execution across the pipeline.
Key Responsibilities:
- Lead process development activities (scale-up, process characterization, technology transfer, manufacturing readiness).
- Serve as CMC Lead; chair cross-functional CMC teams and align plans across Process Development, Formulation, Analytical, Quality, Regulatory, Clinical Manufacturing, Supply Chain, and external partners.
- Develop and execute phase-appropriate CMC strategies for Phase 2/3, registration, process validation, PPQ, and commercial launch readiness.
- Own or contribute to Module 3 / IND / NDA / MAA CMC sections; support health authority interactions and ensure regulatory alignment (FDA/EMA/others).
- Lead technology transfer; establish manufacturing control strategies and ensure scalable, robust, compliant processes.
- Partner with Quality to support GMP discipline, data integrity, investigations, SOP alignment, and inspection readiness; mitigate quality/compliance risks while maintaining development agility.
- Manage departmental resources/budgets and align capabilities with program needs and corporate priorities.
- Build and lead a high-performing Process Development team.
- Identify/manage CMC risks; drive mitigation plans; escalate early with options and tradeoffs.
Qualifications:
- PhD (or 18+ years) in relevant engineering/sciences; or MS/BS with 20+ years relevant pharmaceutical development experience.
- Significant people-management experience.
- Experience leading Process Development / MS&T / Technical Operations / CMC for complex pharmaceutical products.
- Proven experience as CMC Lead or program technical leader.
- Late-phase experience (ideally Phase 3 execution, NDA/MAA preparation, process validation, PPQ planning, launch readiness).
- Strong understanding of drug product/substance, analytical, formulation, development, manufacturing, and regulatory CMC interdependencies.
- Technology transfer experience (internal sites and/or CDMOs).
- Experience authoring/reviewing/defending regulatory CMC sections and supporting health authority questions/inspections.
- Strong communication/collaboration with senior stakeholders; ability to work in a fast-paced, resource-constrained environment.
Preferred Skills:
- Inhaled drug products/dry powder inhalers/particle-engineered products/drug-device combinations.
- Took a product through late-stage development to regulatory submission/validation/approval/launch.
- QbD/control strategy, process characterization, continued process verification, lifecycle management.
- Experience with FDA/EMA/notified bodies on CMC/manufacturing-readiness.
- Built/improved CMC infrastructure, operating models, decision frameworks, SOPs/templates/governance.
- Led through technical disagreement and quality interface issues with collaborative decision-making.
Location/Work Model:
Danbury, CT; onsite Monday–Thursday, Fridays remote.
Pay Range:
$224,000 - $336,000 per year.
The Process Development & CMC Lead provides strategic and technical leadership for the Process Development group and serves as the CMC Lead for one or more development programs. Responsibilities include process development, scale-up, technology transfer, manufacturing readiness, and integrated CMC execution across the pipeline.
Key Responsibilities:
- Lead process development activities (scale-up, process characterization, technology transfer, manufacturing readiness).
- Serve as CMC Lead; chair cross-functional CMC teams and align plans across Process Development, Formulation, Analytical, Quality, Regulatory, Clinical Manufacturing, Supply Chain, and external partners.
- Develop and execute phase-appropriate CMC strategies for Phase 2/3, registration, process validation, PPQ, and commercial launch readiness.
- Own or contribute to Module 3 / IND / NDA / MAA CMC sections; support health authority interactions and ensure regulatory alignment (FDA/EMA/others).
- Lead technology transfer; establish manufacturing control strategies and ensure scalable, robust, compliant processes.
- Partner with Quality to support GMP discipline, data integrity, investigations, SOP alignment, and inspection readiness; mitigate quality/compliance risks while maintaining development agility.
- Manage departmental resources/budgets and align capabilities with program needs and corporate priorities.
- Build and lead a high-performing Process Development team.
- Identify/manage CMC risks; drive mitigation plans; escalate early with options and tradeoffs.
Qualifications:
- PhD (or 18+ years) in relevant engineering/sciences; or MS/BS with 20+ years relevant pharmaceutical development experience.
- Significant people-management experience.
- Experience leading Process Development / MS&T / Technical Operations / CMC for complex pharmaceutical products.
- Proven experience as CMC Lead or program technical leader.
- Late-phase experience (ideally Phase 3 execution, NDA/MAA preparation, process validation, PPQ planning, launch readiness).
- Strong understanding of drug product/substance, analytical, formulation, development, manufacturing, and regulatory CMC interdependencies.
- Technology transfer experience (internal sites and/or CDMOs).
- Experience authoring/reviewing/defending regulatory CMC sections and supporting health authority questions/inspections.
- Strong communication/collaboration with senior stakeholders; ability to work in a fast-paced, resource-constrained environment.
Preferred Skills:
- Inhaled drug products/dry powder inhalers/particle-engineered products/drug-device combinations.
- Took a product through late-stage development to regulatory submission/validation/approval/launch.
- QbD/control strategy, process characterization, continued process verification, lifecycle management.
- Experience with FDA/EMA/notified bodies on CMC/manufacturing-readiness.
- Built/improved CMC infrastructure, operating models, decision frameworks, SOPs/templates/governance.
- Led through technical disagreement and quality interface issues with collaborative decision-making.
Location/Work Model:
Danbury, CT; onsite Monday–Thursday, Fridays remote.
Pay Range:
$224,000 - $336,000 per year.